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

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Other: High Glycemic Diet; Other: Low Glycemic Diet

• Registration Number: NCT03499509
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Study Start: 2019-03-19
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Glycemic Diet	High Glycemic Diet	-
Low Glycemic Diet	Low Glycemic Diet	-

Primary Outcome Measures

Name	Time	Method
Body composition	10 months	Body composition will be measured using Dual Energy X-Ray Absorptiometry (DXA) scan.
Resting energy expenditure	10 months	Resting energy expenditure will be measured by indirect calorimetry.
Total energy expenditure	4 months	Total energy expenditure will be measured by doubly labeled water.
Metabolic efficiency	4 months	Metabolic efficiency will be measured by submaximal exercise test.

Secondary Outcome Measures

Name	Time	Method
Self-reported adherence of each diet	10 months	Self-reported adherence of each diet will be measured by interview.

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States