Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Diet-specific changes in secondary bile acid
研究概览
简要总结
The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-Hispanic, black or white
- •age 19-65 years
- •BMI >= 30 kg/m^2
- •able to visit Bionutrition Unit daily
排除标准
- •gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
- •antibiotic or probiotic use in the previous 90 days
- •tobacco use
- •heavy alcohol consumption
- •major medical conditions (e.g., renal disease, diabetes, cancer)
结局指标
主要结局
Diet-specific changes in secondary bile acid
时间窗: baseline to day 42
The investigators will calculate changes in cholic acid in milligrams.
Mean Weight Change of Participants
时间窗: Baseline to day 42
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Diet-specific changes in inflammatory marker
时间窗: baseline to day 42
The investigators will calculate changes in c-reactive protein in mg/L.
Diet-specific changes in short chain fatty acids
时间窗: baseline to day 42
The investigators will calculate changes in acetic acid in mmol/L
次要结局
未报告次要终点