Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 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
This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function.
详细描述
Short-term active feeding study:
The investigators will provide various chickpea products to participants for a 14 day chickpea enhanced diet. Subjects will receive specific meal plan instructions for the consumption of 5 servings/week of chickpeas. Chickpea products will be sourced from commercial providers. While participants will be told to substitute chickpea products for other diet ingredients, the subjects will be free to choose what to substitute according to their preferences. Subjects will keep daily food records and will be told that chickpea consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day 1), during (Day 7-9) and at the end (Day 14) of the intervention using a stool collection kit (Sigma). Participants will complete our GI health questionnaire on a weekly basis to determine tolerance to increased chickpea intake. An open ended questionnaire will be administered after participants have completed the short-term study protocol to assess any issues with compliance to chickpea intake. All individuals that increased their chickpea intake from their usual diet by at least 3 servings/week will be included in the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 chickpeas or >6 servings/week of legumes BEFORE study begins
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 7-9, and Day 14)
Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples. The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available. This measure is the average amount of OTUs found for each time point.
次要结局
未报告次要终点