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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet | Experimental | Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet. |
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| Therapeutic Lifestyles Changes Diet | Active Comparator | Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and ~15% protein as energy. Fat intake will comprise <7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Behavioral | Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) | Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance. | Baseline, 12 Weeks |
| Change in cognitive performance on the Mini-Mental State Exam (MMSE) | Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance. | Baseline, 12 Weeks |
| Change in cognitive performance on the Logical Memory Test (LMT) | The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story immediately. | Baseline, 12 Weeks |
| Change in cognitive performance by Stroop test | Reaction time and accuracy will be assessed by a psychometrician using the Stroop test. | Baseline, 12 Weeks |
| Change in Clinical Dementia Rating (CDR) | The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed. | Baseline, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral concentration of N-Acetylaspartate (NAA) | Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner. | Baseline, 12 Weeks |
| Change in blood platelet mitochondrial function |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood ketone levels induced by ketogenic diet | We will measure serum beta-hydroxybutyrate levels. | Baseline, 6 Weeks, 12 Weeks |
| Proportion of days positive for urinary ketone production | Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Science Unit | Fairway | Kansas | 66205 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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All outcomes assessors are masked from participant group assignment.
| Therapeutic Lifestyles Changes Diet | Behavioral | Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein. |
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Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm.
| Baseline, 6 Weeks, 12 Weeks |
| Change in self-reported symptoms by study partner | Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners. | Baseline, 6 Weeks, 12 Weeks |
| Daily for 90 days (the length of the diet intervention) |
| Dietary intake characterization prior to and after ketogenic diet initiation | Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners. | Baseline, 6 Weeks, 12 Weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |