Back to resultsEffect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Fruit Diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, whole fruit, diabetes remission, glycemic control, liver fat, intrahepatic lipid, controlled feeding trial
Eligibility Criteria
Inclusion Criteria:
- 20-65 years old
- BMI between 27.0-45.0 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
Sites / Locations
- Department of Nutrition Sciences, University of Alabamam at BirminghamRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-Fruit Diet
Arm Description
Outcomes
Primary Outcome Measures
Diabetes remission rate
Remission rate will be measured in two ways. At the end of Phase II, it will be quantified as the percentage of patients who achieve non-diabetic levels of fasting glucose without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.. During the Follow-up period, it will be quantified as the percentage of patients who achieve non-diabetic levels of both fasting glucose and HbA1c without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.
Diabetes medication usage
As quantified by the Medication Effect Score
Fasting glucose
mg/dl
HbA1c
percentage
2-hour glucose tolerance
mg/dl
Mean glucose during a 3-hour Oral Glucose Tolerance Test (OGTT)
mg/dl
Mean insulin during a 3-hour OGTT
mU/l
Mean C-peptide during a 3-hour OGTT
ng/ml
Fasting insulin
mU/l
Fasting C-peptide
ng/ml
Insulin sensitivity
Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral Minimal Model
Insulin secretion
Beta-cell responsivity index during a 3-hour OGTT, as measured by the Oral Minimal Model
Beta-cell function
Insulinogenic index as measured during the first 15 minutes of a 3-hour OGTT
Mean 24-hour glucose levels, peak glucose levels, and mean amplitude of glycemic excursions (MAGE), as measured using continuous glucose monitoring
mg/dl
Secondary Outcome Measures
Intrahepatic lipid (liver fat)
Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)
Fasting lipids
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Systolic and diastolic blood pressure
mm Hg
Heart rate
beats per minute
Number of cardiovascular medications used
Number for each category of medication (e.g., anti-hypertensive medications)
Dosage of cardiovascular medications used
Dosages for each category of medication (e.g., anti-hypertensive medications)
Full Information
NCT ID
NCT03758742
First Posted
November 16, 2018
Last Updated
June 30, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03758742
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
Detailed Description
Pre-registration notes: The primary endpoint is glycemic control, which will be analyzed hierarchically in descending order of importance as:
Diabetes remission rate (endpoint #1)
Medication effect score (endpoint #2)
Fasting glucose and HbA1c (endpoints #3-4)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes, whole fruit, diabetes remission, glycemic control, liver fat, intrahepatic lipid, controlled feeding trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Fruit Diet
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
High-Fruit Diet
Intervention Description
Participants will consume a diet rich in whole fruit. During Phase I (Weeks 1-4; supervised controlled feeding), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In Phase II (Week 5-12; supervised controlled feeding), 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 during Phases I and II. In the Follow-Up Phase (Months 4-12; free-living), participants will be instructed to continue consuming at least one-third of their diet as whole fruit and to make healthy food choices.
Primary Outcome Measure Information:
Title
Diabetes remission rate
Description
Remission rate will be measured in two ways. At the end of Phase II, it will be quantified as the percentage of patients who achieve non-diabetic levels of fasting glucose without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.. During the Follow-up period, it will be quantified as the percentage of patients who achieve non-diabetic levels of both fasting glucose and HbA1c without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.
Time Frame
Change from baseline (Week 0) to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Diabetes medication usage
Description
As quantified by the Medication Effect Score
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Fasting glucose
Description
mg/dl
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
HbA1c
Description
percentage
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
2-hour glucose tolerance
Description
mg/dl
Time Frame
Change from baseline to Weeks 4 and 12
Title
Mean glucose during a 3-hour Oral Glucose Tolerance Test (OGTT)
Description
mg/dl
Time Frame
Change from baseline to Weeks 4 and 12
Title
Mean insulin during a 3-hour OGTT
Description
mU/l
Time Frame
Change from baseline to Weeks 4 and 12
Title
Mean C-peptide during a 3-hour OGTT
Description
ng/ml
Time Frame
Change from baseline to Weeks 4 and 12
Title
Fasting insulin
Description
mU/l
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Fasting C-peptide
Description
ng/ml
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Insulin sensitivity
Description
Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral Minimal Model
Time Frame
Change from baseline to Weeks 4 and 12
Title
Insulin secretion
Description
Beta-cell responsivity index during a 3-hour OGTT, as measured by the Oral Minimal Model
Time Frame
Change from baseline to Weeks 4 and 12
Title
Beta-cell function
Description
Insulinogenic index as measured during the first 15 minutes of a 3-hour OGTT
Time Frame
Change from baseline to Weeks 4 and 12
Title
Mean 24-hour glucose levels, peak glucose levels, and mean amplitude of glycemic excursions (MAGE), as measured using continuous glucose monitoring
Description
mg/dl
Time Frame
Change from baseline to Weeks 4 and 12
Secondary Outcome Measure Information:
Title
Intrahepatic lipid (liver fat)
Description
Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to Weeks 4 and 12
Title
Fasting lipids
Description
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Systolic and diastolic blood pressure
Description
mm Hg
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Heart rate
Description
beats per minute
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Number of cardiovascular medications used
Description
Number for each category of medication (e.g., anti-hypertensive medications)
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Dosage of cardiovascular medications used
Description
Dosages for each category of medication (e.g., anti-hypertensive medications)
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Other Pre-specified Outcome Measures:
Title
Body weight
Description
kg
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Waist circumference
Description
cm
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Pancreatic fat
Description
Percentage as measured using MRS and 3-point M-Dixon MRI methods
Time Frame
Change from baseline to Weeks 4 and 12
Title
Visceral fat
Description
kg as measured using MRI
Time Frame
Change from baseline to Weeks 4 and 12
Title
Subcutaneous abdominal fat
Description
kg as measured using MRI
Time Frame
Change from baseline to Weeks 4 and 12
Title
Gut microbiome diversity
Description
Diversity metrics (i.e., alpha and beta diversity)
Time Frame
Change from baseline to Weeks 4 and 12
Title
Gut microbiome composition
Description
Taxonomic composition and abundances
Time Frame
Change from baseline to Weeks 4 and 12
Title
Transcriptome
Description
Fold change in gene expression within blood cells (includes pathway analyses)
Time Frame
Change from baseline to Weeks 4 and 12
Title
Preference and sensitivity to sweet tastes
Description
As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test
Time Frame
Change from baseline to Weeks 4 and 12
Title
Caloric intake
Description
kcal/day as measured using 7-day food records
Time Frame
Change from baseline to Week 4 and follow-up Month 12
Title
Macronutrient composition
Description
Percentage of calories as measured using 7-day food records
Time Frame
Change from baseline to Week 4 and follow-up Month 12
Title
Diet satisfaction
Description
As measured on a 0-100 mm visual analog scale (VAS)
Time Frame
Change from baseline to Weeks 4 and 12
Title
Food intake
Description
Percent intake of individual food categories as measured using 7-day food records
Time Frame
Change from baseline to Week 4 and follow-up Month 12
Title
Habitual fruit consumption
Description
As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire
Time Frame
Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Title
Food cravings
Description
As measured on five-point scales by the Food Craving Inventory-II
Time Frame
Change from baseline to Weeks 4 and 12
Title
Fruit type preferences
Description
As measured by VAS on a 0-100 mm scale
Time Frame
Change from baseline to Weeks 4 and 12
Title
Food attitudes and behaviors
Description
As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, which covers constructs including attitudes and beliefs, fruit and vegetable consumption, eating behaviors, and food preferences
Time Frame
Change from baseline to Weeks 4 and 12
Title
General health status
Description
Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire
Time Frame
Change from baseline to Weeks 4 and 12
Title
Depression
Description
As measured on a 0-27 point scale by the Patient Health Questionnaire-9
Time Frame
Change from baseline to Weeks 4 and 12
Title
Mood states
Description
As measured on a 5-point scale by the Profile of Mood States Short-Form
Time Frame
Change from baseline to Weeks 4 and 12
Title
Intervention satisfaction and feedback
Description
As measured by qualitative exit interview
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-65 years old
BMI between 27.0-45.0 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney M. Peterson, Ph.D.
Phone
205-934-0122
Email
cpeterso@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cody J. Hanick, M.S.
Phone
205-934-5458
Email
chanick@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney M. Peterson, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition Sciences, University of Alabamam at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Peterson, Ph.D.
Phone
205-934-0122
Email
cpeterso@uab.edu
First Name & Middle Initial & Last Name & Degree
Cody Hanick, M.S.
Phone
(262) 923-0672
Email
chanick@uab.edu
First Name & Middle Initial & Last Name & Degree
Courtney Peterson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Cody Hanick, M.S.
12. IPD Sharing Statement
Learn more about this trial
Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
We'll reach out to this number within 24 hrs