An interventional study of Low Glycemic Diet and High Glycemic Diet in Diet Modification, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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: Low 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.
Other: High 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.
Also known as: Low Carbohydrate 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.
Also known as: Low Fat Diet
Total Energy Expenditure
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.
Time frame: Baseline, Week 13
| Milestone | Low Glycemic Diet | High Glycemic Diet |
|---|---|---|
| Started | 34 | 33 |
| Completed | 23 | 21 |
| Not completed | 11 | 12 |
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.
| kcal/day | Low Glycemic Diet | High Glycemic Diet |
|---|---|---|
| Baseline | 2411 ± 342 | 2316 ± 289 |
| week 13 | 2318 ± 362 | 2179 ± 413 |
Collected over 13 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Glycemic Diet | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| High Glycemic Diet | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Low Glycemic Diet | High Glycemic Diet | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 33 | 67 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Low Glycemic Diet | High Glycemic Diet | Total |
|---|---|---|---|
| Female | 34 | 33 | 67 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Low Glycemic Diet | High Glycemic Diet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 34 | 33 | 67 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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University of Alabama at Birmingham