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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499509
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Gower, 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.

Condition or disease Intervention/treatment Phase
Diet Modification Other: Low Glycemic Diet Other: High Glycemic Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Glycemic Diet Other: Low Glycemic Diet
Low Glycemic (LG) diet: The LG diet will be made up of foods that do not stimulate insulin secretion. The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement "shakes" (e.g., High-Protein SlimFast). Dinner will be a frozen entrée (e.g., Atkins, Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be nuts, berries, and full-fat dairy products (one serving per day), and will be used to adjust the calorie level of each day's meals to individual calorie needs.

Placebo Comparator: High Glycemic Diet Other: High Glycemic Diet
High Glycemic (HG) diet: The HG diet will conform to United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/). The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement "shakes" (e.g., SlimFast). Dinner will be a frozen entrée (e.g., Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be fruit, fat-free dairy products, and low-fat bars (e.g., Optifast), and will be used to adjust the calorie level of each day's meals to individual calorie needs.




Primary Outcome Measures :
  1. Body composition [ Time Frame: 10 months ]
    Body composition will be measured using Dual Energy X-Ray Absorptiometry (DXA) scan.

  2. Resting energy expenditure [ Time Frame: 10 months ]
    Resting energy expenditure will be measured by indirect calorimetry.

  3. Total energy expenditure [ Time Frame: 4 months ]
    Total energy expenditure will be measured by doubly labeled water.

  4. Metabolic efficiency [ Time Frame: 4 months ]
    Metabolic efficiency will be measured by submaximal exercise test.


Secondary Outcome Measures :
  1. Self-reported adherence of each diet [ Time Frame: 10 months ]
    Self-reported adherence of each diet will be measured by interview.



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499509


Contacts
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Contact: Laura Lee Goree, MS, RD, LD 205-934-4386 LLG@uab.edu

Locations
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United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Laura Lee Goree, MS, RD, LD    205-934-4386    LLG@uab.edu   
Principal Investigator: Barbara Gower, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Barbara Gower, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03499509    
Other Study ID Numbers: R01DK115483-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms