Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Total Energy Expenditure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 30-45 kg/m2
- •Sedentary to moderately active (<2 hours/wk of moderate, structured, intentional exercise.
- •Normal menstrual cycle
排除标准
- •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.
结局指标
主要结局
Total Energy Expenditure
时间窗: 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.
次要结局
未报告次要终点
研究者
Barbara Gower
Professor
University of Alabama at Birmingham