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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 20 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 20-70 years old - BMI ≤45.0 kg/m^2 - First diagnosed with type 2 diabetes within the past 6 years - HbA1c between 6.0-9.5%%

Exclusion Criteria

  • On insulin - Diagnosis of diabetes before age 18 - Estimated glomerular filtration rate < 45 ml/min per 1.732 m^2 - Heart attack in the past 6 months or severe or unstable heart failure - On weight loss medication - Change in the dosage of a chronic medication that may affect study endpoints within the past 3 months - Clinically significant laboratory abnormality (e.g. abnormal hemoglobin levels) - Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones - Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise safety or data validity - Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years - Lost or gained more than 5 kg of weight in the past 6 months - Pregnant, planning to become pregnant in the next 12 months, or breastfeeding - Major psychiatric condition that would affect the ability to participate in the study - Not able to eat the provided study meals - Behavioral factors or circumstances that may impede adhering to the dietary intervention - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High-Fruit Diet 		Whole fruit-rich diet (~50% of calories from whole fruit)
  • Behavioral: 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.

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.