Gastrointestinal MicrobiomeMultigutNCT05371704
The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function
A study testing Multivitamin Supplementation and Dietary Replication in people with Gastrointestinal Microbiome, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome
- What is being tested?
- Multivitamin Supplementation and Dietary Replication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults >18 y
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
Glasgow, G312ER
About this study
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.
Read the 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
- Being tested
- Multivitamin Supplementation, Dietary Replication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin SupplementationDietary supplement
Participants will supplement daily with an over-the-counter oral multivitamin pill
Dietary ReplicationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary Replication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition during multivitamin supplementation
Changes will be assessed via 16S rRNA gene amplicon sequencing from DNA extracts of faecal samples
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start28 Sep 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Konstantinos Gerasimidis, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371704
- Sponsor's protocol ID
- Version 1
- Acronym
- Multigut
- Status last verified
- May 2022
- First submitted
- 3 Feb 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40645132
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function
- ClinicalTrials.gov ID
- NCT05371704
- Acronym / sponsor ID
- Multigut / Version 1
- Conditions
- Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Multivitamin Supplementation, Other: Dietary ReplicationIn 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. |
| Control | Other | Other: Dietary ReplicationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults >18 y
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin SupplementationParticipants will supplement daily with an over-the-counter oral multivitamin pill | Dietary supplement | Supplementation |
| Dietary ReplicationPatients 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 | Other | Control, Supplementation |
Primary outcome
Changes in gut microbiota composition during multivitamin supplementation
Time frame: 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 concentrations of faecal and urinary metabolites during multivitamin supplementation
Time frame: 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 bacterial metabolites during multivitamin supplementation
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 40645132Mckirdy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin Supplementation and Dietary Replication in people with Gastrointestinal Microbiome, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota composition during multivitamin supplementation (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.