High-Fruit Diet for Type 2 Diabetes

Overseen by Courtney M. Peterson, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 that comprise the Mediterranean diet, 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 induce diabetes remission and can improve blood sugar, liver fat, and cardiovascular health in adults with type 2 diabetes. Thereafter, participants will be followed for up to one year. As a secondary aim, this study will also test whether consuming a large amount of fructose in whole food form negatively affects liver fat and cardiovascular health.

Research Team

Courtney M. Peterson, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Adults aged 20-65 with type 2 diabetes, diagnosed in the last 6 years and having an HbA1c level of 6.0-9.5%, can join this trial if they have a BMI between 27.0-45.0 kg/m^2 and are not on insulin or weight loss medication, pregnant, or have significant health issues that could interfere with the study.

Inclusion Criteria

Your body mass index (BMI) is between 27.0 and 45.0 kg/m^2.

HbA1c between 6.0-9.5% is considered a 'high risk' for developing diabetes.

I am between 20 and 65 years old.

Exclusion Criteria

I do not have major heart, kidney, liver, lung, adrenal gland, or nervous system diseases.

You have habits or situations that may make it difficult for you to follow the study's required diet.

Not able to do the MRI/MRS abdominal scan, such as due to claustrophobia, implanted metal objects, or a body girth of 60 cm or greater

Treatment Details

Interventions

• High-Fruit Diet (Behavioural Intervention)

Trial Overview The trial is testing whether a high-fruit diet over a period of 12 weeks can help adults with type 2 diabetes improve their blood sugar control and possibly achieve diabetes remission while also looking at effects on liver fat and heart health.

Participant Groups

Group I: High-Fruit Diet Experimental Treatment 1 Intervention

Whole fruit-rich diet (\~50% of calories from whole fruit)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham