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Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction

Primary Purpose

Diet Modification

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Glycemic Diet
High Glycemic Diet
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet Modification

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 30-45 kg/m2
  • Sedentary to moderately active (<2 hours/wk of moderate, structured, intentional exercise.
  • Normal menstrual cycle

Exclusion Criteria:

  • History of eating disorder
  • daily use of tobacco (>1 pack/wk)
  • change in weight greater than 5 pounds in previous 3 months
  • presence of any condition (e.g. PCOS) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes
  • applicants will be screened with a standard oral glucose tolerance test. If a participant's 2 hour glucose if >200, they will not be able to enroll in the study.

Sites / Locations

  • The University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low Glycemic Diet

High Glycemic Diet

Arm Description

Outcomes

Primary Outcome Measures

Body composition
Body composition will be measured using Dual Energy X-Ray Absorptiometry (DXA) scan.
Resting energy expenditure
Resting energy expenditure will be measured by indirect calorimetry.
Total energy expenditure
Total energy expenditure will be measured by doubly labeled water.
Metabolic efficiency
Metabolic efficiency will be measured by submaximal exercise test.

Secondary Outcome Measures

Self-reported adherence of each diet
Self-reported adherence of each diet will be measured by interview.

Full Information

First Posted
April 4, 2018
Last Updated
August 3, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03499509
Brief Title
Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
Official Title
Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Scientific Premise of this study is that the high level of obesity displayed by African American (AA) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. When AA women eat a diet rich in starchy or sugary food (a "high-glycemic" diet that stimulates insulin secretion), the food that is eaten is stored as fat rather than being burned as fuel. The investigators previous research has suggested that AA women have an easier time losing weight and keeping it off when eating a low-glycemic diet. The proposed study will be the first randomized clinical trial to test the effect of high and low glycemic diets for weight loss and weight-loss-maintenance in obese AA women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Glycemic Diet
Arm Type
Experimental
Arm Title
High Glycemic Diet
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Low Glycemic Diet
Intervention Description
Low Glycemic (LG) diet: The LG diet will be made up of foods that do not stimulate insulin secretion. The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement "shakes" (e.g., High-Protein SlimFast). Dinner will be a frozen entrée (e.g., Atkins, Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be nuts, berries, and full-fat dairy products (one serving per day), and will be used to adjust the calorie level of each day's meals to individual calorie needs.
Intervention Type
Other
Intervention Name(s)
High Glycemic Diet
Intervention Description
High Glycemic (HG) diet: The HG diet will conform to United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/). The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement "shakes" (e.g., SlimFast). Dinner will be a frozen entrée (e.g., Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be fruit, fat-free dairy products, and low-fat bars (e.g., Optifast), and will be used to adjust the calorie level of each day's meals to individual calorie needs.
Primary Outcome Measure Information:
Title
Body composition
Description
Body composition will be measured using Dual Energy X-Ray Absorptiometry (DXA) scan.
Time Frame
10 months
Title
Resting energy expenditure
Description
Resting energy expenditure will be measured by indirect calorimetry.
Time Frame
10 months
Title
Total energy expenditure
Description
Total energy expenditure will be measured by doubly labeled water.
Time Frame
4 months
Title
Metabolic efficiency
Description
Metabolic efficiency will be measured by submaximal exercise test.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Self-reported adherence of each diet
Description
Self-reported adherence of each diet will be measured by interview.
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 30-45 kg/m2 Sedentary to moderately active (<2 hours/wk of moderate, structured, intentional exercise. Normal menstrual cycle Exclusion Criteria: History of eating disorder daily use of tobacco (>1 pack/wk) change in weight greater than 5 pounds in previous 3 months presence of any condition (e.g. PCOS) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes applicants will be screened with a standard oral glucose tolerance test. If a participant's 2 hour glucose if >200, they will not be able to enroll in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrienna Stephens
Phone
205-975-6579
Email
as1217@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Lee Goree
Phone
205-934-4386
Email
LLG@uab.edu
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienna Stephens
Phone
205-975-6579
Email
as1217@uab.edu
First Name & Middle Initial & Last Name & Degree
Laura Lee Goree, MS, RD, LD
Phone
205-934-4386
Email
LLG@uab.edu
First Name & Middle Initial & Last Name & Degree
Barbara Gower, PhD

12. IPD Sharing Statement

Learn more about this trial

Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction

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