NCT05242913已完成不适用
A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora
Manitoba Starch Products2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
研究概览
简要总结
This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.
排除标准
- •Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.
结局指标
主要结局
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
时间窗: Four weeks
Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.
次要结局
- Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups(One week)
- Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups(One week, four weeks)
- Fecal SCFA (mmol/kg stool) changes from baseline(One week, four weeks)
- Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores(One week, four weeks)
- Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale(One week, four weeks)
研究者
研究点 (2)
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