Assessing the Short-Term Effects of Multi-Fiber Supplementation on Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 主要终点
- Change in metagenomically inferred SCFA production potential
研究概览
简要总结
This is a randomized, parallel-group interventional study evaluating the short-term gastrointestinal effects of a standardized multi-fiber supplement in healthy adults. Approximately 100 participants (50 per arm) aged 18 and older will be randomized to receive either the multi-fiber supplement or a control (flavoring agent only) daily for 10 days. Objectives include assessing effects on stool characteristics, specifically frequency and consistency, as well as changes in metagenomically inferred short-chain fatty acid production potential from the microbiota. Eligible participants must be free of chronic disease, acute illness, and recent antibiotic, probiotic, or prebiotic use. Total participation duration is 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in self-reported good health (i.e. no chronic disease, no acute illness)
排除标准
- •chronic disease
- •acute illness
- •antibiotic, or probiotic, or prebiotic use in the prior 3 months
- •allergies to any of the following: psyllium husk powder, mustard, sesame, soy, tree nuts, pectin, citric acid, wheat, milk, egg, beta-glucan, barley, inulin, agave, resistant maltodextrin, arabinoxylan
- •adherence to any food-group strict diet (e.g. vegan, vegetarian, keto, etc.)
- •any of the following groups: adults unable to consent, individuals that are not yet adult, pregnant women, prisoners
结局指标
主要结局
Change in metagenomically inferred SCFA production potential
时间窗: Change observed from baseline sample (Day 0) to second sample (Day 10)
Through metagenomic sequencing analysis, change in relative abundance of short-chain fatty acid producing genes from sequenced timepoint stool samples will be assessed.
次要结局
- Bowel Movement Regularity(Change observed over time from baseline (Day 0) through completion of the study (Day 10))