Trial Outcomes & Findings for Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes (NCT NCT03758742)
NCT ID: NCT03758742
Last Updated: 2025-06-10
Results Overview
Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12
COMPLETED
NA
34 participants
Change from baseline to week 12
2025-06-10
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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34
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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22
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
High-Fruit Diet
n=10 Participants
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.
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Age, Continuous
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56 years
STANDARD_DEVIATION 8 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Change from baseline to week 12Population: Results were analyzed per-protocol in completers who met the specified weight stability criterion
Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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|---|---|
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Diabetes Remission Rate
% Who Maintained Non-Diabetic Glycemia Without Pharmacotherapy
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3 Participants
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Diabetes Remission Rate
% Who Weaned Off All Antihyperglycemic Medications
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6 Participants
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PRIMARY outcome
Timeframe: Change from baseline to Week 12Population: Results were analyzed per-protocol in completers who met the specified weight stability criterion
% (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.
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Medication Effect Score (MES)
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-0.5 % (see definition under "Description")
Standard Error 0.5
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PRIMARY outcome
Timeframe: 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.Population: 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.
mg/dl
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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|---|---|
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Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT)
All n=10 participants, including those who changed their medication doses
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11 mg/dl
Standard Error 9
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Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT)
n=4 participants without medication changes
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-20 mg/dl
Standard Error 12
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PRIMARY outcome
Timeframe: 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.Population: Results were analyzed per-protocol in completers who met the specified weight stability criterion
mg/dl
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES
Main Analysis
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-12 mg/dl
Standard Error 7
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Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES
Post Hoc Analysis Excluding 1 Outlier with Very Low C-peptide Levels
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-18 mg/dl
Standard Error 6
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SECONDARY outcome
Timeframe: 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.Population: 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.
Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model.
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Insulin Sensitivity
All n=10 participants, including those who changed their medication doses
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1.27 dl/kg/min/μU/ml
Standard Error 0.99
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Insulin Sensitivity
n=4 participants without medication changes
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3.03 dl/kg/min/μU/ml
Standard Error 1.61
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SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Dynamic Beta-Cell Responsivity
All n=10 participants, including those who changed their medication doses
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135 arbitrary units * 10^9
Standard Error 60
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Dynamic Beta-Cell Responsivity
n=4 participants without medication changes
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122 arbitrary units * 10^9
Standard Error 133
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SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Static Beta-Cell Responsivity
All n=10 participants, including those who changed their medication doses
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-3.0 10^9/min
Standard Error 4.0
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Static Beta-Cell Responsivity
n=4 participants without medication changes
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0.9 10^9/min
Standard Error 10.6
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SECONDARY outcome
Timeframe: 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.Population: 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
mU/l
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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|---|---|
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Mean Insulin During a 3-hour OGTT
All n=10 participants, including those who changed their medication doses
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-17.1 mU/l
Standard Error 4.7
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Mean Insulin During a 3-hour OGTT
n=4 participants without medication changes
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-38.1 mU/l
Standard Error 6.7
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SECONDARY outcome
Timeframe: 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.Population: 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
ng/ml
Outcome measures
| Measure |
Fruit-Rich Diet
n=10 Participants
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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Mean C-peptide During a 3-hour OGTT
All n=10 participants, including those who changed their medication doses
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-0.4 ng/ml
Standard Error 0.4
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Mean C-peptide During a 3-hour OGTT
n=4 participants without medication changes
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-1.7 ng/ml
Standard Error 0.5
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SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)"mg/dl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)mg/dl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)percentage
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Percentage as measured using MRS and 3-point M-Dixon MRI methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)mm Hg
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)beats per minute
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Time during which glucose levels are between 70 and 300 mg/dl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Fasting total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints); assessed weeklykg
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)cm
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Visceral fat as measured using MRI (kg)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Subcutaneous abdominal fat as measured using MRI (kg)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Diversity metrics (i.e., alpha and beta diversity)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Taxonomic composition and abundances
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured on a 0-100 mm visual analog scale (VAS)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured on five-point scales by the Food Craving Inventory-II
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured by VAS on a 0-100 mm scale
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured on a 0-27 point scale by the Patient Health Questionnaire-9
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)As measured on a 5-point scale by the Profile of Mood States Short-Form
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12As measured by qualitative exit interview
Outcome measures
Outcome data not reported
Adverse Events
High-Fruit Diet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High-Fruit Diet
n=34 participants at risk
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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|---|---|
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Metabolism and nutrition disorders
Hypoglycemia
|
52.9%
18/34 • 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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Metabolism and nutrition disorders
Hyperglycemia
|
44.1%
15/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Gastrointestinal disorders
Mild Stomach Pain
|
11.8%
4/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Nervous system disorders
Mild Tremor
|
8.8%
3/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
General disorders
Fatigue
|
5.9%
2/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.9%
2/34 • Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.
Participants were queried about adverse events at each study visit.
|
Additional Information
Dr. Courtney M. Peterson
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place