MedPath

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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
67
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High Glycemic DietHigh Glycemic Diet-
Low Glycemic DietLow Glycemic Diet-
Primary Outcome Measures
NameTimeMethod
Total Energy ExpenditureBaseline, Week 13

Total energy expenditure measured by doubly labeled water. The protocol is based on established procedures \[12\]. Urine samples are analyzed in duplicate for H218O and 2H2O enrichments using Thermo Scientific Delta V Advantage IRMS with GasBench. CO2 production rates are determined using a fixed assumption for the dilution space ratio (1.043), using Equation 3 of Speakman et al. \[10\], and energy expenditure is calculated with equation 5 of Speakman et al. \[10\].

\[10\] Speakman JR, Yamada Y, Sagayama H et al. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med 2021; 2:100203.

\[12\] Goran MI, Carpenter WH, McGloin A et al. Energy expenditure in children of lean and obese parents. American Journal of Physiology 1995; 31:E917-E924.

\[13\] Wolfe RR. Measurement of Total Energy Expenditure Using the Doubly-Labeled Water Method. In: Radioactive and Stable Isotope Tracers in Biomedicine. Edited by: Wiley-Liss. 1992.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

© Copyright 2025. All Rights Reserved by MedPath