The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

Gastrointestinal Microbiome Clinical Trial

— Multigut  

Official title:

The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05371704
• Other study ID #: Version 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: February 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adults >18 y

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

Intervention

Dietary Supplement:
• Multivitamin Supplementation
Participants will supplement daily with an over-the-counter oral multivitamin pill

Other:
• Dietary Replication
Patients will record their dietary intake in an estimated food diary during the first trial. During the second trial, participants will be asked to replicate their diet from the first trial

Locations

Country	Name	City	State
United Kingdom	School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut microbiota composition during multivitamin supplementation	Changes will be assessed via 16S rRNA gene amplicon sequencing from DNA extracts of faecal samples	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.
Primary	Changes in concentrations of faecal and urinary metabolites during multivitamin supplementation	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.	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.
Primary	Changes in bacterial metabolites during multivitamin supplementation	Changes in targeted bacterial metabolites including short chain fatty acids, sulphide, ammonia, lactate, succinate, ethanol	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.