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临床试验/NCT04538482
NCT04538482已完成不适用

Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2022年3月7日最近更新:
适应症
干预措施

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

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

Experimental

calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber)

干预措施: DASH Diet (Behavioral)

standard American diet

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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