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Clinical Trials/NCT03499509
NCT03499509
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country67 target enrollmentMarch 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet Modification
Sponsor
University of Alabama at Birmingham
Enrollment
67
Locations
1
Primary Endpoint
Total Energy Expenditure
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2019
End Date
April 30, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Gower

Professor

University of Alabama at Birmingham

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Total Energy Expenditure

Time Frame: Baseline, 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.

Study Sites (1)

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