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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK079626 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes.
One such approach is adopting a healthy diet, which can dramatically improve blood sugar levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not much is known about which food groups are most effective at improving blood sugar levels in patients with diabetes.
Interestingly, of the various food groups, epidemiologic data suggests that whole fruit may be one of the most efficacious at both preventing type 2 diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical trials have investigated the effects of whole fruit on blood sugar control. This study will therefore be the first to determine the effects of increasing whole fruit as a food group in type 2 diabetes patients. This supervised controlled feeding trial will test whether consuming a diet rich in whole fruit for 12 weeks can improve glycemic control and cardiometabolic health in weight-stable adults with type 2 diabetes. The primary endpoint is glycemic control. Since changes in medication doses can skew the interpretation of glycemic outcomes, glycemic control will be assessed hierarchically (in descending order of importance) using (a) attainment of nondiabetic glycemia without medications (as a proxy for diabetes remission), (b) medication effect scores, (c) mean glucose during an oral glucose tolerance test, and (d) 24-hour mean glucose from continuous glucose monitoring. As secondary aims, this study will also test whether consuming a large amount of fructose in whole food form affects liver fat, pancreatic fat, and cardiovascular disease risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Fruit Diet | Experimental | Whole fruit-rich diet (~50% of calories from whole fruit) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Fruit Diet | Behavioral | In this supervised controlled feeding study, participants will consume a diet rich in whole fruit. During the Ramp-Up Phase (Weeks 1-4), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In the Main Phase (Weeks 5-12), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable throughout the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Remission Rate | Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12 | Change from baseline to week 12 |
| Medication Effect Score (MES) | % (or percentage). This quantity estimates the percentage by which all anithyperglycemic medications taken by a patient would lower HbA1c levels (i.e., percent of glycated hemoglobin molecules). Higher values indicate a higher dose and/or potency of medications. | Change from baseline to Week 12 |
| Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT) | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model. | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Dynamic Beta-Cell Responsivity |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | kg | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints); assessed weekly |
| Waist Circumference | cm |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney M. Peterson, Ph.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition Sciences, University of Alabamam at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24651807 | Background | Cobelli C, Dalla Man C, Toffolo G, Basu R, Vella A, Rizza R. The oral minimal model method. Diabetes. 2014 Apr;63(4):1203-13. doi: 10.2337/db13-1198. | |
| 39978247 | Derived | Hanick CJ, Berg KJ, Garvey WT, Goss AM, Steger FL, Richman JS, Peterson CM. Study protocol, menu design, and rationale for a study testing the effects of a whole fruit-rich diet on glycemic control, liver fat, pancreatic fat, and cardiovascular health in adults with type 2 diabetes. Nutr Res. 2025 Mar;135:82-100. doi: 10.1016/j.nutres.2025.01.008. Epub 2025 Jan 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Fruit Diet | Whole fruit-rich diet (~50% of calories from whole fruit) In this supervised controlled feeding study, participants will consume a diet rich in whole fruit. During the Ramp-Up Phase (Weeks 1-4), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In the Main Phase (Weeks 5-12), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable throughout the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Results were analyzed only per-protocol, as is the norm for controlled feeding trials. In our study, per-protocol was defined as (a) completing the study with >=80% adherence and (b) meeting the weight stability criterion. Twelve participants completed the study, and of these, ten also met the weight stability criterion.
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Fruit Diet | Whole fruit-rich diet (~50% of calories from whole fruit) High-Fruit Diet: Participants will consume a diet rich in whole fruit. During Phase I (Weeks 1-4; supervised controlled feeding), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In Phase II (Week 5-12; supervised controlled feeding), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable during Phases I and II. In the Follow-Up Phase (Months 4-12; free-living), participants will be instructed to continue consuming at least one-third of their diet as whole fruit and to make healthy food choices. |
| 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 | Diabetes Remission Rate | Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12 | Results were analyzed per-protocol in completers who met the specified weight stability criterion | Posted | Count of Participants | Participants | Change from baseline to week 12 |
|
Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Fruit Diet | Whole fruit-rich diet (~50% of calories from whole fruit) High-Fruit Diet: In this supervised controlled feeding study, participants will consume a diet rich in whole fruit. During the Ramp-Up Phase (Weeks 1-4), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In the Main Phase (Weeks 5-12), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable throughout the intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | <70 mg/dl |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney M. Peterson | University of Alabama at Birmingham | 205-934-0122 | cpeterso@uab.edu |
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| 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 | Mar 19, 2022 | Nov 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Lab values and week 0, 4, and 12 endpoints are assessed blinded by individuals not affiliated with the protocol. Also, data cleaning will be performed while being blinded to the timepoint.
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Phi_dynamic during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi_dynamic is a measure of beta-cell responsiveness during first-phase insulin secretion. It is a dimensionless index (arbitrary units), where higher values denote greater insulin secretion. |
| Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Static Beta-Cell Responsivity | Phi_static during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi_static is a measure of beta-cell responsiveness during second-phase insulin secretion. The units of measure are min^-1, and higher values denote greater insulin secretion. | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Mean Insulin During a 3-hour OGTT | mU/l | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Mean C-peptide During a 3-hour OGTT | ng/ml | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
| Mean Amplitude of Glycemic Excursions From CGM | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)" |
| Fasting Glucose | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| HbA1c | percentage | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Liver Fat (Intrahepatic Lipid) | Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Pancreatic Fat | Percentage as measured using MRS and 3-point M-Dixon MRI methods | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Systolic and Diastolic Blood Pressure | mm Hg | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Heart Rate | beats per minute | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Time-in-range Metrics From CGM | Time during which glucose levels are between 70 and 300 mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Lipids | Fasting total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Visceral Fat | Visceral fat as measured using MRI (kg) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Subcutaneous Abdominal Fat | Subcutaneous abdominal fat as measured using MRI (kg) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Gut Microbiome Diversity | Diversity metrics (i.e., alpha and beta diversity) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Gut Microbiome Composition | Taxonomic composition and abundances | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Preference and Sensitivity to Sweet Tastes | As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Diet Satisfaction | As measured on a 0-100 mm visual analog scale (VAS) | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Habitual Fruit Consumption | As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire | Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12 |
| Food Cravings | As measured on five-point scales by the Food Craving Inventory-II | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Fruit Liking Visual Analog Scales | As measured by VAS on a 0-100 mm scale | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Food Attitudes and Behaviors | As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, which covers constructs including attitudes and beliefs, fruit and vegetable consumption, eating behaviors, and food preferences | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| General Health Status | Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Depression | As measured on a 0-27 point scale by the Patient Health Questionnaire-9 | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Mood States | As measured on a 5-point scale by the Profile of Mood States Short-Form | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) |
| Intervention Satisfaction and Feedback | As measured by qualitative exit interview | Week 12 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Medication Effect Score (MES) | % (or percentage). This quantity estimates the percentage by which all anithyperglycemic medications taken by a patient would lower HbA1c levels (i.e., percent of glycated hemoglobin molecules). Higher values indicate a higher dose and/or potency of medications. | Results were analyzed per-protocol in completers who met the specified weight stability criterion | Posted | Least Squares Mean | Standard Error | % (see definition under "Description") | Change from baseline to Week 12 |
|
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| Primary | Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT) | mg/dl | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness only. | Posted | Mean | Standard Error | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
|
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| Primary | Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES | mg/dl | Results were analyzed per-protocol in completers who met the specified weight stability criterion | Posted | Least Squares Mean | Standard Error | mg/dl | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
|
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| Secondary | Insulin Sensitivity | Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model. | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness only. | Posted | Mean | Standard Error | dl/kg/min/μU/ml | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
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| Secondary | Dynamic Beta-Cell Responsivity | Phi_dynamic during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi_dynamic is a measure of beta-cell responsiveness during first-phase insulin secretion. It is a dimensionless index (arbitrary units), where higher values denote greater insulin secretion. | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness only. | Posted | Mean | Standard Error | arbitrary units * 10^9 | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
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|
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| Secondary | Static Beta-Cell Responsivity | Phi_static during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi_static is a measure of beta-cell responsiveness during second-phase insulin secretion. The units of measure are min^-1, and higher values denote greater insulin secretion. | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness only. | Posted | Mean | Standard Error | 10^9/min | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
|
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| Secondary | Mean Insulin During a 3-hour OGTT | mU/l | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness | Posted | Mean | Standard Error | mU/l | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
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| Secondary | Mean C-peptide During a 3-hour OGTT | ng/ml | We present the results both in all participants (n=10) and those who were on stable doses of medications (n=4). The former data is presented for completeness | Posted | Mean | Standard Error | ng/ml | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported. |
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| Secondary | Mean Amplitude of Glycemic Excursions From CGM | mg/dl | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)" | Participants |
| Secondary | Fasting Glucose | mg/dl | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | HbA1c | percentage | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Liver Fat (Intrahepatic Lipid) | Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Pancreatic Fat | Percentage as measured using MRS and 3-point M-Dixon MRI methods | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Systolic and Diastolic Blood Pressure | mm Hg | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Heart Rate | beats per minute | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Time-in-range Metrics From CGM | Time during which glucose levels are between 70 and 300 mg/dl | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Secondary | Lipids | Fasting total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Body Weight | kg | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints); assessed weekly | Participants |
| Other Pre-specified | Waist Circumference | cm | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Visceral Fat | Visceral fat as measured using MRI (kg) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Subcutaneous Abdominal Fat | Subcutaneous abdominal fat as measured using MRI (kg) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Gut Microbiome Diversity | Diversity metrics (i.e., alpha and beta diversity) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Gut Microbiome Composition | Taxonomic composition and abundances | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Preference and Sensitivity to Sweet Tastes | As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Diet Satisfaction | As measured on a 0-100 mm visual analog scale (VAS) | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Habitual Fruit Consumption | As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire | Not Posted | Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12 | Participants |
| Other Pre-specified | Food Cravings | As measured on five-point scales by the Food Craving Inventory-II | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Fruit Liking Visual Analog Scales | As measured by VAS on a 0-100 mm scale | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Food Attitudes and Behaviors | As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, which covers constructs including attitudes and beliefs, fruit and vegetable consumption, eating behaviors, and food preferences | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | General Health Status | Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Depression | As measured on a 0-27 point scale by the Patient Health Questionnaire-9 | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Mood States | As measured on a 5-point scale by the Profile of Mood States Short-Form | Not Posted | Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints) | Participants |
| Other Pre-specified | Intervention Satisfaction and Feedback | As measured by qualitative exit interview | Not Posted | Week 12 | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| 18 |
| 34 |
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | >300 mg/dl |
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| Mild Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
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| Mild Tremor | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
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Not provided
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| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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