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

Diet Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03499509
• Other study ID #: R01DK115483-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification
• Obesity

Intervention

Other:
• Low Glycemic Diet
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.
• High Glycemic Diet
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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Body composition will be measured using Dual Energy X-Ray Absorptiometry (DXA) scan.	10 months
Primary	Resting energy expenditure	Resting energy expenditure will be measured by indirect calorimetry.	10 months
Primary	Total energy expenditure	Total energy expenditure will be measured by doubly labeled water.	4 months
Primary	Metabolic efficiency	Metabolic efficiency will be measured by submaximal exercise test.	4 months
Secondary	Self-reported adherence of each diet	Self-reported adherence of each diet will be measured by interview.	10 months