Clinical trial NCT03758742: Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
Official title: Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
whole fruit
diabetes remission
glycemic control
liver fat
intrahepatic lipid
controlled feeding trial
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-11-29
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diabetes Remission Rate
timeFrame: Change from baseline to week 12
measure: Medication Effect Score (MES)
timeFrame: Change from baseline to Week 12
measure: Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT)
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.
measure: Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES
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.
Secondary outcomes:
measure: Insulin Sensitivity
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.
measure: Dynamic Beta-Cell Responsivity
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.
measure: Static Beta-Cell Responsivity
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.
measure: Mean Insulin During a 3-hour OGTT
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.
measure: Mean C-peptide During a 3-hour OGTT
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.
measure: Mean Amplitude of Glycemic Excursions From CGM
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)"
measure: Fasting Glucose
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: HbA1c
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Liver Fat (Intrahepatic Lipid)
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Pancreatic Fat
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Systolic and Diastolic Blood Pressure
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Heart Rate
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Time-in-range Metrics From CGM
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Lipids
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
Other outcomes:
measure: Body Weight
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints); assessed weekly
measure: Waist Circumference
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Visceral Fat
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Subcutaneous Abdominal Fat
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Gut Microbiome Diversity
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Gut Microbiome Composition
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Preference and Sensitivity to Sweet Tastes
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Diet Satisfaction
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Habitual Fruit Consumption
timeFrame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
measure: Food Cravings
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Fruit Liking Visual Analog Scales
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Food Attitudes and Behaviors
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: General Health Status
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Depression
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Mood States
timeFrame: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)
measure: Intervention Satisfaction and Feedback
timeFrame: Week 12
Locations:
city: Birmingham
country: United States
facility: Department of Nutrition Sciences, University of Alabamam at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Courtney M. Peterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobelli C, Dalla Man C, Toffolo G, Basu R, Vella A, Rizza R. The oral minimal model method. Diabetes. 2014 Apr;63(4):1203-13. doi: 10.2337/db13-1198.