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

NCT03499509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-05-18

Study results available
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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.

Conditions

  • Diet Modification

Interventions

OTHER

Low Glycemic Diet

Low Glycemic (LG) diet: The LG diet was made up of foods that do not stimulate insulin secretion and was composed of 20% CHO, 55% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet.

OTHER

High Glycemic Diet

High Glycemic (HG) diet: The HG diet aligned with the United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/) and was composed of 55% CHO, 20% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Barbara Gower, PhD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499509 on ClinicalTrials.gov