The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

NCT ID: NCT05371704

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-02-01

Brief 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.

Detailed 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).

Conditions

Gastrointestinal Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Supplementation

In this arm of the study, participants will take 1 multivitamin pill each day for 10 days. If this is the participant's first trial, they will also record their diet in a 10-day estimated food diary. If this is the participant's second trial, they will replicate their diet recorded from their first trial.

Group Type: EXPERIMENTAL

Multivitamin Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Participants will supplement daily with an over-the-counter oral multivitamin pill

Dietary Replication

Intervention Type: OTHER

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

Control

In this arm of the study, participants will not supplement with any multivitamin. If this is the participant's first trial, they will record their diet in a 10-day estimated food diary. If this is the participant's second trial, they will replicate the diet recorded from their first trial.

Group Type: OTHER

Dietary Replication

Intervention Type: OTHER

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

Interventions

Multivitamin Supplementation

Participants will supplement daily with an over-the-counter oral multivitamin pill

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Dr Konstantinos Gerasimidis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Countries

United Kingdom

References

Mckirdy S, Koutsos A, Nichols B, Anderson M, Dhami S, Chowdhury CR, Mascellani Bergo A, Havlik J, Gerasimidis K. Micronutrient supplementation influences the composition and diet-originating function of the gut microbiome in healthy adults. Clin Nutr. 2025 Aug;51:293-303. doi: 10.1016/j.clnu.2025.06.020. Epub 2025 Jun 25.

Reference Type: DERIVED

PMID: 40645132 (View on PubMed)

Other Identifiers

Version 1

Identifier Type: -

Identifier Source: org_study_id