Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Diet-specific changes in inflammatory marker
研究概览
简要总结
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •black or white race
- •non-Hispanic ethnicity
- •age 19-65 years
- •able to travel to the UAB Bionutrition Unit daily to retrieve meals
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
- •smoking/tobacco use
- •heavy alcohol consumption
- •major medical conditions (e.g., renal disease, diabetes, cancer
研究组 & 干预措施
DASH Diet
calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber)
干预措施: DASH Diet (Behavioral)
standard American diet
calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber)
干预措施: standard American diet (Behavioral)
结局指标
主要结局
Diet-specific changes in inflammatory marker
时间窗: day 28 - day 42
The investigators will calculate changes in interleukin-6 in pg/L
Diet specific changes in secondary bile acids
时间窗: day 28 - day 42
The investigators will calculate changes in cholic acid in milligrams
Mean change in alpha diversity
时间窗: day 28 - day 42
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Diet specific changes in secondary bile acids
时间窗: baseline - day 28
The investigators will calculate changes in cholic acid in milligrams
Mean change in alpha diversity
时间窗: baseline - day 28
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Diet-specific changes in inflammatory marker
时间窗: baseline - day 28
The investigators will calculate changes in interleukin-6 in pg/L
次要结局
未报告次要终点
