The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

NCT05371704 | Unknown

• 1 other identifier: Version 1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Multivitamin Supplementation; Other: Dietary Replication

Control

OTHER

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.

Other: Dietary Replication

Interventions

Multivitamin Supplementation DIETARY_SUPPLEMENT

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

Supplementation

Dietary Replication 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; Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults \>18 y

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

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

Glasgow, G312ER, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40645132 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: May 12, 2022
• Study Start: September 28, 2021
• Primary Completion: September 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

GB (1)