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

  • STATUS
    Recruiting
  • participants needed
    21
  • sponsor
    University of Alabama at Birmingham
Updated on 28 January 2023

Summary

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.

Description

Pre-registration notes: The primary endpoint is glycemic control, which will be analyzed hierarchically in descending order of importance as:

  1. Diabetes remission rate (endpoint #1)
  2. Medication effect score (endpoint #2)
  3. Fasting glucose and HbA1c (endpoints #3-4)
  4. Oral glucose tolerance test and continuous glucose monitoring measures (endpoints #5-14)

while the secondary endpoints (endpoints #15-20) will all be evaluated with equal importance.

Details
Condition type ii diabetes, Diabetes Mellitus Type 2, diabetes type 2, Diabetes Mellitus, Type 2, NIDDM, noninsulin-dependent diabetes mellitus, type 2 diabetes, type 2 diabetes mellitus
Treatment High-Fruit Diet
Clinical Study IdentifierNCT03758742
SponsorUniversity of Alabama at Birmingham
Last Modified on28 January 2023

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