Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time.
研究概览
简要总结
Raisins contain a significant amount of dietary fiber and polyphenolic compounds that represent an important substrate for microbiota fermentation which generates potentially beneficial end products, such as short-chain fatty acids. The mammalian gut contains a phylogenetically as well as functionally diverse microbiota that contributes to host physiology. To date, little is known about how increased raisin intake affects human gut microbiota composition.
This research study will assess the effects of adding raisins to the diet of healthy adults on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function. The hypothesis is that by adding raisins to the diet this will result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be beneficial, as evaluated by an increase in butyrate producers and bacteria associated with anti-inflammatory properties.
详细描述
The research study design is a 14 day international focus on increasing raising intake. Participants will be provided with a commercial raisin product for a 14 day period. Participants will consume 2 servings/day (84g of raisins). While participants will be told to substitute raisins for other diet ingredients, they will be free to choose what to substitute according to their preferences. Participants will keep daily food records and will be told that raisin consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day1), during (Day5-7) and at the end (Day 12-14) of the intervention using a stool collection kit (Sigma). Participants will complete a GI health questionnaire on a weekly basis to determine tolerance to increased raisin intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good Health
- •No systemic antibiotics during the preceding two months
- •No medication suppressing immune function
- •Willingness to provide basic demographic as well as medical history data
排除标准
- •Gastric Ulcers
- •Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
- •Chronic constipation/diarrhea
- •Body Mass Index (BMI) > 30
- •Dietary restrictions that prevent legume intake
- •Currently on any medication that can affect GI transit time
- •Consumption of >3 servings/week of raisins BEFORE study begins
研究组 & 干预措施
Raisins Enhanced Diet
Participants will be provide with a Raisin Enhanced Diet over a short term period of time.
干预措施: Raisins (Other)
结局指标
主要结局
Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time.
时间窗: Change in Baseline (Day 1), Day 9, and Day 14
Compare the overall gut microbial diversity of individual subjects before and after the implementation of a controlled and observed diet of raisins, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.
次要结局
未报告次要终点