Efficacy of Yeast Mannan Supplementation on Increasing Stool Frequency in Generally Healthy Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Defecation frequency
研究概览
简要总结
Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline. The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day. Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who report a stool frequency of ≤ 1 per day.
- •Able to provide written informed consent in English.
- •Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days.
- •Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements.
- •Willing to comply with study procedures, including stool and urine colle
排除标准
- •Stool frequency of < 3 per week
- •Yeast allergy
- •Vegan dietary pattern
- •Self-reported kidney disease
- •Elite athletes or long-distance runners
- •Use of antibiotic drugs within 1 month of screening
- •Current use of laxatives or antidiarrheal medications
- •Use of other investigational products within 3 months of the screening
- •Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
- •Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection).
- •Current cancer treatment.
- •Currently pregnant.
研究组 & 干预措施
Yeast mannan supplementation
Yeast cell wall fraction obtained from Saccharomyces cerevisiae containing mannan-oligosaccharides and mannoproteins will be supplemented at 12 g/day.
干预措施: Yeast mannan (Dietary Supplement)
Control supplementation
The control supplement, containing yeast protein, yeast extract, and maltodextrin, will be provided at 12 g/day.
干预措施: Control (placebo) (Dietary Supplement)
结局指标
主要结局
Defecation frequency
时间窗: From enrollment to the end of treatment at 6 weeks.
Mean daily defecation frequency
次要结局
未报告次要终点