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

The University of Alabama at Birmingham

Status: Completed

Conditions: Diet Modification

Treatments: Other: Low Glycemic Diet; Other: High Glycemic Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03499509

R01DK115483-01A1

IRB-300001324

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups, including a placebo group

Low Glycemic Diet

Experimental group

Description:

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.

Treatment:

Other: Low Glycemic Diet

High Glycemic Diet

Placebo Comparator group

Description:

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.

Treatment:

Other: High Glycemic Diet