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临床试验/NCT05197218
NCT05197218已完成不适用

Prebiotic Properties of Phenolic Compounds

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Number of daily anal gas evacuations

研究概览

简要总结

Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria. Within subjects, gas output varies in relation to the diet. However, there is a great interindividual variability: gas evacuation in subjects maintained on a similar diet may differ substantially, and this depends on the composition and metabolic pathways of the colonic microbiota. Hence, the volume of gas production and anal evacuation is determined by two main factors: the diet, particularly the amount of fermentable residues, and the individual composition of colonic microbiota. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production and may induce gas-related symptoms. However, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production and the initial symptoms disappear. Some data suggest that phenolic compounds have prebiòtic properties. Aim of the study: to explore the prebiotic effect of a combination of two polyphenol-rich berry extracts (cranberry and chokeberry). Design: single-centre, single arm, open label, proof-of-concept study in healthy subjects. Intervention: a combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days. Outcomes: during 2 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • gastrointestinal symptoms
  • recent (3 months) antibiotic intake
  • change in dietary habits 4 weeks before

研究组 & 干预措施

Healthy subjects

Experimental

Prebiotic administration

干预措施: Prebiotic (Dietary Supplement)

结局指标

主要结局

Number of daily anal gas evacuations

时间窗: 18 days

Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

次要结局

  • Microbiota composition by fecal analysis(18 days)
  • Sensation of flatulence by scales(18 days)
  • Sensation of abdominal bloating by scales(18 days)
  • Sensation of digestive well-being by scales(18 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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