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临床试验/NCT05371704
NCT05371704Unknown不适用

The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

University of Glasgow2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Changes in concentrations of faecal and urinary metabolites during multivitamin supplementation

研究概览

简要总结

The main aim of this randomized crossover study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers. Participants will undertake two 10-day trials with a replicated diet separated by a 15-day washout period. For one of these trials, participants will take a daily over-the-counter multivitamin supplement. Faecal and urine samples will be collected at the start and end of each trial to assess changes in gut microbiota composition, urinary and faecal metabolomics, and targeted bacterial metabolites including short chain fatty acids, sulphide, and lactate.

详细描述

Exploring the effect of habitual dietary patterns on human gut microbiota and on host health is an area of scientific interest and a major funding theme in UKRI. The main aim of this proof-of-concept study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers.

Participants will be asked to undertake two trials with 15 day washout in-between. If the participants are allocated to the "supplementation group" they will be asked to consume an over-the-counter multivitamin supplement for 10 days (1 tablet per day) in addition to their usual diet. Participants will provide faecal and urinary samples prior to initiation of the intervention and again at the end of the 10-day supplementation. During these 10 days participants will be asked to record the meals they consume on provided food diaries. If the participants are allocated to the "control group", participants will be asked to provide the same number of samples and at the same intervals as the supplementation group (i.e. at baseline and after 10 days) but without receiving micronutrient supplementation. Participants will also be asked to replicate as close as possible the diet they had followed during the first trial they were allocated. Between the two trials, participants will follow a wash-out period of 15 days with the aim of reverting the gut microbiota characteristics back to baseline levels.

The main outcome measures of this study are to assess changes in gut microbiota composition based on 16S rRNA gene amplicon sequencing, changes in urinary/faecal metabolomics, and changes in targeted bacterial metabolites (short chain fatty acids, sulphide, lactate).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Healthy adults >18 y

排除标准

  • History of previous major gut surgery,
  • Unstable weight,
  • Use of pre/probiotics, micronutrient supplements, antibiotics, or steroids the last 3 months
  • Participation in other research

结局指标

主要结局

Changes in concentrations of faecal and urinary metabolites during multivitamin supplementation

时间窗: This will be assessed 4 times throughout the study. This will be assessed at the beginning (day 0) and end (day 10) of each 10-day trial.

Concentration of several urinary and faecal metabolites will be assessed via 1H NMR spectroscopy in urine and faecal samples from study participants. Changes during multivitamin supplementation will be investigated.

Changes in gut microbiota composition during multivitamin supplementation

时间窗: This will be assessed 4 times throughout the study. This will be assessed at the beginning (day 0) and end (day 10) of each 10-day trial.

Changes will be assessed via 16S rRNA gene amplicon sequencing from DNA extracts of faecal samples

Changes in bacterial metabolites during multivitamin supplementation

时间窗: This will be assessed 4 times throughout the study. This will be assessed at the beginning (day 0) and end (day 10) of each 10-day trial.

Changes in targeted bacterial metabolites including short chain fatty acids, sulphide, ammonia, lactate, succinate, ethanol

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Konstantinos Gerasimidis

Professor

University of Glasgow

研究点 (2)

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