Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 15-AG-0123 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background:
- Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease.
Objectives:
- To compare two forms of diet and their effects on insulin resistance and the brain.
Eligibility:
- Women ages 55 70 with insulin resistance.
Design:
Being overweight or obese can cause insulin resistance (IR), which is defined as reduced responsiveness to insulin by the cells of various tissues or organs. IR at midlife increases the risk of developing Alzheimer s disease (AD). We recently discovered novel biomarkers of brain IR (altered Tyr and Ser phosphorylated forms of insulin receptor substrate 1; IRS-1) in plasma exosomes enriched for neuronal origin. Moreover, IR is associated with AD biomarkers including deficits in resting state brain activity and cognitive performance. Calorie restriction is defined as consuming fewer calories than what is considered normal without a lack of nutrients. A certain type of calorie restriction, in which one consumes 500-600 calories a day for two consecutive days, followed by non-restricted eating for 5 days (5-2 CR), has been shown to lower peripheral insulin resistance effectively. Effects of CR and lowering peripheral IR on brain IR and cognition are unknown. The goal of this exploratory pilot study is to provide proof-of-concept that 5-2 CR at midlife can reverse brain IR, lower peripheral IR, improve cognitive performance, and increase brain activation at rest and during tasks. Specifically, we will study the effects of 8 weeks of 5-2 CR versus a control dietary intervention on brain and peripheral IR, memory and executive function, resting state default mode network activity, brain metabolism, and AD biomarkers. Forty overweight to obese women and men (between 55 and 70 years of age) will be randomized 1:1 into 5-2 CR and control groups. In the 5-2 CR group, participants will be offered healthy living dietary counseling at baseline, which they will be instructed to implement for five days/week. For each of the other two consecutive days/week, they will consume two shakes (Boost , CWI Medical), providing a total of 480 Kcal/day. In the control group, participants will be offered healthy living dietary counseling at baseline, which they will be asked to implement for every day of the week. Participants will undergo screening including a history and physical examination, calculation of Body Mass Index (BMI, which must be greater than or equal to 27) and a blood draw for insulin and glucose to determine whether they have insulin resistance. If participants meet eligibility criteria, they will continue with a baseline visit involving anthropometric measures, questionnaires, tests of cognitive function, brain MRI, blood draws for plasma and peripheral blood mononuclear cells, and lumbar puncture for cerebrospinal fluid biomarkers of AD. After 8 weeks, we will collect the same measures. To assess and reinforce compliance with their respective diet, participants will come into the clinic every 2 weeks to discuss compliance, measure their body weight and perform blood draws for measurement of ketones to objectively confirm energy restriction for the 5-2 CR group. We will also contact participants every week to further ensure compliance. To assess the effects of the diets on physical activity, participants will be asked to wear an accelerometer for 96 hours before and after they are on the diet.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-2 CR | Experimental | Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. |
|
| Healthy Living Diet | Active Comparator | Healthy living diet for 7 days/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boost (R) 5-2 diet | Other | Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1) | IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in serine residues resulting in impaired downstream signal propagation. pS312-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) P-pan-Tyrosine-IRS-1 (pY-IRS-1) | IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in tyrosine residues resulting in impaired downstream signal propagation. pY-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR. | Week 0, Week 4, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Body Weight | Week 0, Week 8 | |
| Mean Change in Body Mass Index (BMI) | Week 0, Week 8 | |
| Mean Change in Waist Circumference |
Not provided
EXCLUSION CRITEIRA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitrios I Kapogiannis, M.D. | National Institute on Aging (NIA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Aging, Clinical Research Unit | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38901423 | Derived | Kapogiannis D, Manolopoulos A, Mullins R, Avgerinos K, Delgado-Peraza F, Mustapic M, Nogueras-Ortiz C, Yao PJ, Pucha KA, Brooks J, Chen Q, Haas SS, Ge R, Hartnell LM, Cookson MR, Egan JM, Frangou S, Mattson MP. Brain responses to intermittent fasting and the healthy living diet in older adults. Cell Metab. 2024 Aug 6;36(8):1668-1678.e5. doi: 10.1016/j.cmet.2024.05.017. Epub 2024 Jun 19. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
.There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Not provided
Not provided
Not provided
Not provided
129 participants underwent screening; 80 were not eligible, 3 withdrew prior to randomization, and 46 participants were randomized, 22 to 5-2 CR and 24 to HL.
Recruitment took place between 22 June 2015 and 23 December 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 5-2 CR | Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Boost (R) 5-2 diet: Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day. |
| FG001 | Healthy Living Diet | Healthy living diet for 7 days/week Healthy Living Diet: Counseling and educational material on diet portion, consistency |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5-2 CR | Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Boost (R) 5-2 diet: Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1) | IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in serine residues resulting in impaired downstream signal propagation. pS312-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-2 CR | Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Boost (R) 5-2 diet: Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dimitrios Kapogiannis | National Institute on Aging | +1-202-290-0433 | kapogiannisd@nih.mail.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2016 | Dec 20, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2020 | Dec 20, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Healthy Living Diet | Other | Counseling and educational material on diet portion, consistency |
|
| Week 0, Week 8 |
| Mean Change in Fasting Glucose | Week 0, Week 8 |
| Mean Change in Fasting Insulin | Week 0, Week 8 |
| Mean Change in Homeostatic Model Assessment of Insulin Resistance 2 (HOMA2-IR) | Homeostatic Model Assessment of Insulin Resistance Index 2 (HOMA2-IR) is a marker of peripheral insulin resistance and is calculated by fasting insulin (μIU/L) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. A cut-off of 1.8 was used to indicate peripheral insulin resistance. | Week 0, Week 8 |
| Mean Change in Glycosylated Hemoglobin (HbA1c) | Week 0, Week 8 |
| Mean Change in White Blood Cells (WBCs) | Week 0, Week 8 |
| Mean Change in Red Blood Cells (RBCs) | Week 0, Week 8 |
| Mean Change in Platelets | Week 0, Week 8 |
| Mean Change in Hemoglobin | Week 0, Week 8 |
| Mean Change in Hematocrit | Week 0, Week 8 |
| Mean Change in International Normalized Ratio (INR) | The International Normalized Ratio (INR) is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. The higher the INR, the longer it takes for blood to clot. | Week 0, Week 8 |
| Mean Change in Serum Beta-Hydroxybutyrate (bHB) | Week 0, Week 8 |
| Mean Change in Serum Acetoacetate (AcAc) | Week 0, Week 8 |
| Mean Change in Serum Non-Esterified Fatty Acids (NEFA) | Week 0, Week 8 |
| Mean Change in Serum Cortisol | Week 0, Week 8 |
| Mean Change in Creatinine | Week 0, Week 8 |
| Mean Change in Blood Urea Nitrogen (BUN) | Week 0, Week 8 |
| Mean Change in Alanine Aminotransferase (ALT) | Week 0, Week 8 |
| Mean Change in Aspartate Aminotransferase (AST) | Week 0, Week 8 |
| Mean Change in Total Cholesterol | Week 0, Week 8 |
| Mean Change in HDL Cholesterol | Week 0, Week 8 |
| Mean Change in LDL Cholesterol | Week 0, Week 8 |
| Mean Change in Triglycerides | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 40 | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 / Amyloid Beta 40 Ratio | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Total Tau | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) p181-Tau | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Neurogranin | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Light Chain Neurofilaments (Nf-L) | Week 0, Week 8 |
| Mean Change in Cerebrospinal Fluid (CSF) Glial Fibrillary Acidic Protein (GFAP) | Week 0, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 40 | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 / Amyloid Beta 40 Ratio | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Total Tau | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p181-Tau | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p231-Tau | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Akt | Akt (or protein kinase B) is an insulin signaling cascade mediator. An increase in its levels indicates an improvement in brain insulin resistance. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) | pS473-Akt is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) / Akt Ratio | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Extracellular Signal-regulated Kinase 1/2 (pERK1/2) | pERK1/2 is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated c-Jun N-terminal Kinase (pJNK) | JNK is an insulin signaling cascade mediator. Activated JNK (pJNK) inhibits insulin signaling. An increase in pJNK levels indicates inhibition of downstream insulin signaling pathway. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated p38 (pp38) | p38 is an insulin signaling cascade mediator. Activated p38 (pp38) inhibits insulin signaling. An increase in pp38 levels indicates inhibition of downstream insulin signaling pathway. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) proBDNF | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) BDNF | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Neurogranin | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Heavy Chain Neurofilaments (Nf-H) | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) A-synuclein | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) TAR DNA-binding Protein 43 (TDP-43) | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 1 (MCT1) | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 2 (MCT2) | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex IV Quantity | Complex IV is part of the mitochondrial electron transport chain. Decreased complex IV levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis. | Week 0, Week 4, Week 8 |
| Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex V Quantity | Complex V is part of the mitochondrial electron transport chain. Decreased complex V levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis. | Week 0, Week 4, Week 8 |
| Mean Change in Glucose by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in N-acetyl-aspartate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Lactate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Gamma-Aminobutyric Acid (GABA) by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Gamma-Aminobutyric Acid (GABA) concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Gamma-Aminobutyric Acid (GABA) relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutamine by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutathione by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Myo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Ascorbate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Alanine by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Scyllo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Scyllo-Inositol relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glucose by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Lactate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutamine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Glutathione by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Myo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Ascorbate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Alanine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | Week 0, Week 8 |
| Mean Change in Executive Function Composite | Executive function was assessed with the National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) battery that comprises written, verbal, and computerized tasks that test working memory, inhibition, set shifting, fluency, planning, insight, and social cognition and behavior. The Executive function Composite is a computerized score calculated based on the individual tests. It ranges between 0 and 10. Higher score values indicate better performance. | Week 0, Week 8 |
| Mean Change in California Verbal Learning Test (CVLT) | California Verbal Learning Test (CVLT) assesses verbal memory for unstructured information. Examinees are asked to recall words on a 16-item list after each of 5 learning trials (Immediate Free Recall; range 0-80 [5 x 0-16]). After a distractor list, participants are again asked to recall words spontaneously (Short Delay Free Recall; range 0-16) and with category cueing (Short Delay Cued Recall; range 0-16). Spontaneous recall (Long Delay Free Recall; range 0-16) and category cueing (Long Delay Cued Recall; range 0-16) are repeated after a 20-minute delay. Following the longer delay, participants also complete a yes/no recognition trial during which they need to discriminate between the target words and 32 distractor words (Long Delay Recognition; range 0-48 [0-16 true positive target words + 0-32 true negative distractor words]). Higher scores indicate better performance. | Week 0, Week 8 |
| Mean Change in Logical Memory (LM) Test | Logical Memory (LM) test assesses verbal memory for structured information. It consists of two thematically independent narrative stories. Each story has 25 items, which the examinee has to recall with as much detail and precision as possible. Each item is scored the same regardless of importance level, and all correct items are summed giving a maximum score of 25 for each story. "Verbatim recall" score only includes the items that are recalled exactly and with detailed information, whereas "gist recall" score includes both the verbatim recall and the items that are recalled with only the essential elements of the information. The examinee has to recall the two stories twice, immediately after their initial administration (immediate recall) and after a 20 to 30-minute delay (delayed recall). Total maximum score for each of the subtests is 50 (25 items x 2 stories) and the minimum score is 0. Higher scores indicate better performance. | Week 0, Week 8 |
| Change in the Positive and Negative Affect Schedule (PANAS) | Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure to assess positive and negative affect and is an index of emotional state. For positive affect, score can range from 10 - 50, with higher scores representing higher levels of positive affect. For negative affect, score can range from 10 - 50, with lower scores representing lower levels of negative affect. | Week 0, Week 8 |
| Mean Change in the Short Form 36-item Health Survey (SF-36) | Short Form 36-item Health Survey (SF-36) is a gauge of physical and psychosocial effects of the interventions. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability; the higher the score the less disability. | Week 0, Week 8 |
| Mean Change in Total Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Daily Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Hourly Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Metabolic Rate | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Time in Activity | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Total Steps | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Steps Per Minute | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| Mean Change in Total Sedentary Bouts | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | Week 0, Week 8 |
| BG001 |
| Healthy Living Diet |
Healthy living diet for 7 days/week Healthy Living Diet: Counseling and educational material on diet portion, consistency |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity was determined by self-report. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Homeostatic Model Assessment of Insulin Resistance 2 (HOMA2-IR) | Mean | Standard Deviation | (μU/mmol/L)2 |
|
| Mini-Mental State Examination (MMSE) score | Scores on the MMSE range from 0 to 30, with lower scores indicating greater impairment. | Mean | Standard Deviation | units on a scale |
|
| ApoE ε4 carrier status | Count of Participants | Participants |
|
| OG001 | Healthy Living Diet | Healthy living diet for 7 days/week Healthy Living Diet: Counseling and educational material on diet portion, consistency |
|
|
| Primary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) P-pan-Tyrosine-IRS-1 (pY-IRS-1) | IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in tyrosine residues resulting in impaired downstream signal propagation. pY-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Body Weight | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | kg | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Body Mass Index (BMI) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | kg/m^2 | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Waist Circumference | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | cm | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Fasting Glucose | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Fasting Insulin | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | μIU/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Homeostatic Model Assessment of Insulin Resistance 2 (HOMA2-IR) | Homeostatic Model Assessment of Insulin Resistance Index 2 (HOMA2-IR) is a marker of peripheral insulin resistance and is calculated by fasting insulin (μIU/L) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. A cut-off of 1.8 was used to indicate peripheral insulin resistance. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | μIU/L*mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glycosylated Hemoglobin (HbA1c) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | percentage | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in White Blood Cells (WBCs) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | cells x 10^9/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Red Blood Cells (RBCs) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | cells x 10^12/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Platelets | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | cells x 10^3/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Hemoglobin | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | g/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Hematocrit | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | percentage | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in International Normalized Ratio (INR) | The International Normalized Ratio (INR) is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. The higher the INR, the longer it takes for blood to clot. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Serum Beta-Hydroxybutyrate (bHB) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Serum Acetoacetate (AcAc) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Serum Non-Esterified Fatty Acids (NEFA) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mEq/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Serum Cortisol | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | ng/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Creatinine | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Blood Urea Nitrogen (BUN) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Alanine Aminotransferase (ALT) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | IU/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Aspartate Aminotransferase (AST) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | IU/L | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Total Cholesterol | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in HDL Cholesterol | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in LDL Cholesterol | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Triglycerides | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 40 | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 / Amyloid Beta 40 Ratio | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Total Tau | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) p181-Tau | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Neurogranin | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Light Chain Neurofilaments (Nf-L) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Cerebrospinal Fluid (CSF) Glial Fibrillary Acidic Protein (GFAP) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 40 | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 / Amyloid Beta 40 Ratio | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Total Tau | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p181-Tau | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p231-Tau | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Akt | Akt (or protein kinase B) is an insulin signaling cascade mediator. An increase in its levels indicates an improvement in brain insulin resistance. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) | pS473-Akt is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) / Akt Ratio | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Extracellular Signal-regulated Kinase 1/2 (pERK1/2) | pERK1/2 is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated c-Jun N-terminal Kinase (pJNK) | JNK is an insulin signaling cascade mediator. Activated JNK (pJNK) inhibits insulin signaling. An increase in pJNK levels indicates inhibition of downstream insulin signaling pathway. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated p38 (pp38) | p38 is an insulin signaling cascade mediator. Activated p38 (pp38) inhibits insulin signaling. An increase in pp38 levels indicates inhibition of downstream insulin signaling pathway. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) proBDNF | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) BDNF | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Neurogranin | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Heavy Chain Neurofilaments (Nf-H) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Measurements with coefficient of variation (CV) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) A-synuclein | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) TAR DNA-binding Protein 43 (TDP-43) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | pg/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 1 (MCT1) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | ng/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 2 (MCT2) | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | ng/mL | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex IV Quantity | Complex IV is part of the mitochondrial electron transport chain. Decreased complex IV levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex V Quantity | Complex V is part of the mitochondrial electron transport chain. Decreased complex V levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Arbitrary Units (AU) | Week 0, Week 4, Week 8 |
|
|
|
| Secondary | Mean Change in Glucose by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in N-acetyl-aspartate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Lactate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Gamma-Aminobutyric Acid (GABA) by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Gamma-Aminobutyric Acid (GABA) concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Gamma-Aminobutyric Acid (GABA) relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutamine by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutathione by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Myo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Ascorbate by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Alanine by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Scyllo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Scyllo-Inositol relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glucose by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Lactate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutamine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Glutathione by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Myo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Ascorbate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Alanine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC) | Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). Metabolite measurements with Cramer-Rao lower bounds (CRLBs) ≥ 20% were excluded from the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Executive Function Composite | Executive function was assessed with the National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) battery that comprises written, verbal, and computerized tasks that test working memory, inhibition, set shifting, fluency, planning, insight, and social cognition and behavior. The Executive function Composite is a computerized score calculated based on the individual tests. It ranges between 0 and 10. Higher score values indicate better performance. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in California Verbal Learning Test (CVLT) | California Verbal Learning Test (CVLT) assesses verbal memory for unstructured information. Examinees are asked to recall words on a 16-item list after each of 5 learning trials (Immediate Free Recall; range 0-80 [5 x 0-16]). After a distractor list, participants are again asked to recall words spontaneously (Short Delay Free Recall; range 0-16) and with category cueing (Short Delay Cued Recall; range 0-16). Spontaneous recall (Long Delay Free Recall; range 0-16) and category cueing (Long Delay Cued Recall; range 0-16) are repeated after a 20-minute delay. Following the longer delay, participants also complete a yes/no recognition trial during which they need to discriminate between the target words and 32 distractor words (Long Delay Recognition; range 0-48 [0-16 true positive target words + 0-32 true negative distractor words]). Higher scores indicate better performance. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Logical Memory (LM) Test | Logical Memory (LM) test assesses verbal memory for structured information. It consists of two thematically independent narrative stories. Each story has 25 items, which the examinee has to recall with as much detail and precision as possible. Each item is scored the same regardless of importance level, and all correct items are summed giving a maximum score of 25 for each story. "Verbatim recall" score only includes the items that are recalled exactly and with detailed information, whereas "gist recall" score includes both the verbatim recall and the items that are recalled with only the essential elements of the information. The examinee has to recall the two stories twice, immediately after their initial administration (immediate recall) and after a 20 to 30-minute delay (delayed recall). Total maximum score for each of the subtests is 50 (25 items x 2 stories) and the minimum score is 0. Higher scores indicate better performance. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, Week 8 |
|
|
|
| Secondary | Change in the Positive and Negative Affect Schedule (PANAS) | Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure to assess positive and negative affect and is an index of emotional state. For positive affect, score can range from 10 - 50, with higher scores representing higher levels of positive affect. For negative affect, score can range from 10 - 50, with lower scores representing lower levels of negative affect. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in the Short Form 36-item Health Survey (SF-36) | Short Form 36-item Health Survey (SF-36) is a gauge of physical and psychosocial effects of the interventions. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability; the higher the score the less disability. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Total Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | kilocalories | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Daily Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | kilocalories/day | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Hourly Energy Expenditure | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | kilocalories/hour | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Metabolic Rate | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | Watts/sec | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Time in Activity | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | percentage of time | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Total Steps | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | steps | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Steps Per Minute | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | steps/minute | Week 0, Week 8 |
|
|
|
| Secondary | Mean Change in Total Sedentary Bouts | Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions. | FAS (full analysis set) is all randomized participants who completed 8 weeks of diet (per protocol population). | Posted | Least Squares Mean | Standard Error | sedentary bouts | Week 0, Week 8 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Healthy Living Diet | Healthy living diet for 7 days/week Healthy Living Diet: Counseling and educational material on diet portion, consistency | 0 | 20 | 0 | 20 | 2 | 20 |
| Lightheadedness | General disorders | Systematic Assessment |
|
| Muscle cramps | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Week 8 - Week 4 |
|
|
| Week 8 - Week 4 |
|
|
| Week 8 - Week 4 |
|
|
| Short Delay Cued Recall |
|
| Long Delay Free Recall |
|
| Long Delay Cued Recall |
|
| Long Delay Recognition |
|
| Delayed Verbatim Recall |
|
| Delayed Gist Recall |
|
| Role limitations due to emotional problems |
|
| Energy/fatigue |
|
| Emotional well-being |
|
| Social functioning |
|
| Pain |
|
| General health |
|
| Time in moderate physical activity |
|
| Time in moderate-to-vigorous physical activity |
|