NCT03758742

Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes

Completed NA Results posted Last updated 10 June 2025

What this trial tests

NA trial testing High-Fruit Diet in Diabetes Mellitus, Type 2 in 34 participants. Completed in 5 September 2023.

Timeline

10 September 2019

Primary endpoint
5 September 2023

5 September 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	10 September 2019
Primary completion	5 September 2023
Estimated completion	5 September 2023
Sites	1 location across United States

Drugs / interventions tested

• High-Fruit Diet

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 20 to 70, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diabetes Remission Rate Primary · Change from baseline to week 12

Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12

% Who Maintained Non-Diabetic Glycemia Without Pharmacotherapy

Group	Value	95% CI
Fruit-Rich Diet	3

% Who Weaned Off All Antihyperglycemic Medications

Group	Value	95% CI
Fruit-Rich Diet	6

Medication Effect Score (MES) Primary · Change from baseline to Week 12

% (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.

Group	Value	95% CI
Fruit-Rich Diet	-0.5	± 0.5

Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT) Primary · 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.

mg/dl

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	11	± 9

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	-20	± 12

Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES Primary · 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.

mg/dl

Main Analysis

Group	Value	95% CI
Fruit-Rich Diet	-12	± 7

Post Hoc Analysis Excluding 1 Outlier with Very Low C-peptide Levels

Group	Value	95% CI
Fruit-Rich Diet	-18	± 6

Insulin Sensitivity Secondary · 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.

Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model.

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	1.27	± 0.99

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	3.03	± 1.61

Dynamic Beta-Cell Responsivity Secondary · 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.

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.

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	135	± 60

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	122	± 133

Static Beta-Cell Responsivity Secondary · 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.

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.

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	-3.0	± 4.0

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	0.9	± 10.6

Mean Insulin During a 3-hour OGTT Secondary · 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.

mU/l

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	-17.1	± 4.7

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	-38.1	± 6.7

Mean C-peptide During a 3-hour OGTT Secondary · 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.

ng/ml

All n=10 participants, including those who changed their medication doses

Group	Value	95% CI
High-Fruit Diet	-0.4	± 0.4

n=4 participants without medication changes

Group	Value	95% CI
High-Fruit Diet	-1.7	± 0.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected at baseline (~1 week) and during Weeks 1 through 12.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High-Fruit Diet

Serious: 0/34 (0%)

Deaths: 0/34

Other adverse events (9 terms — click to expand)

Reaction	System	High-Fruit Diet
Hypoglycemia	Metabolism and nutrition disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Mild Stomach Pain	Gastrointestinal disorders	—
Mild Tremor	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Fatigue	General disorders	—
Diarrhea	Gastrointestinal disorders	—
Peripheral Sensory Neuropathy	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03758742 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Hanick CJ, Berg KJ, Garvey WT, Goss AM, et al · · 2025 · cited 1× · PMID 39978247 · DOI 10.1016/j.nutres.2025.01.008
2. Mitochondrial DNA DAMPs, Inflammation, and Insulin Sensitivity After Dietary Interventions in Adults with Type 2 Diabetes.
   Cedillo YE, Sammy MJ, Taylor MG, Hanick CJ, et al · · 2025 · PMID 41156500 · DOI 10.3390/nu17203248