Healthy VolunteersVitaGutNCT03668964
Effect of Nutrition Ingredients on Microbiota Modulation
A study testing Vitamin B2, Vitamin C and Vitamin B2 + C in people with Healthy Volunteers, run by dsm-firmenich Switzerland AG at 1 site in Ireland.
Trial summary
The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vitamin B2, Vitamin C and Vitamin B2 + C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIreland
- Study dates
- 20 Aug 2018to 15 Jul 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
- Be between 20 and 50 years of age;
- Has a BMI of between 18.5 - 30 Kg/m2;
- Has a stable body weight (< 5% change) over the past 3-months;
- Is in general good health, as determined by the investigator;
- Willing to avoid consuming dietary supplements, prebiotic, probiotic, dietary or fibre rich supplements within 4 weeks prior to baseline visit, until the end of the study;
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- Willing to avoid liver consumption during the intervention
- Maintain current level of physical activity;
- Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
- Willing to consume the investigational product daily for the duration of the study.
Who cannot join
- Females are pregnant, lactating or wish to become pregnant during the study.
- Are hypersensitive to any of the components of the test product;
- Has taken antibiotics within the previous 3 months;
- Has a history of drug and/or alcohol abuse at the time of enrolment;
- Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
- Is a smoker;
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- Has made any major dietary changes in the past 3 months;
- Subject is planning a sun or ski holiday over the duration of the study;
- Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- Has an eating disorder;
- Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
- Is using fibre supplements or enemas;
- Has a high fiber diet (i.e. >30 g) based on FFQ;
- Has an active gastrointestinal disorder or previous gastrointestinal surgery,
- If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
- Has a metabolic, psychiatric, or gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
- Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- Have a malignant disease or any concomitant end-stage organ disease;
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.
- Conditions
- Healthy Volunteers
- Being tested
- Vitamin B2, Vitamin C, Vitamin B2 + C, Vitamin A, Vitamin D3
- Keywords
- Intestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B2Dietary supplement
Also called Riboflavin
One capsule of 75 mg Vitamin B2 once a day for 4 weeks
Vitamin CDietary supplement
One capsule of 500 mg Vitamin C once a day for 4 weeks
Vitamin B2 + CDietary supplement
One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks
Vitamin ADietary supplement
One capsule of 250 µg Vitamin A once a day for 4 weeks
Vitamin D3Dietary supplement
Also called Cholecalciferol
One capsule of 60 µg Vitamin D3 once a day for 4 weeks
Vitamin EDietary supplement
Also called alpha-tocopherol
One capsule of 100 mg Vitamin E once a day for 4 weeks
PlaceboDietary supplement
One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B2 | Experimental | Daily dose of 75 mg Vitamin B2 Receives: Dietary Supplement: Vitamin B2 |
| Vitamin C | Experimental | Daily dose of 500 mg Vitamin C Receives: Dietary Supplement: Vitamin C |
| Vitamin B2 + C | Experimental | Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C Receives: Dietary Supplement: Vitamin B2 + C |
| Vitamin A | Experimental | Daily dose of 250 µg Vitamin A Receives: Dietary Supplement: Vitamin A |
| Vitamin D3 | Experimental | Daily dose of 60 µg Vitamin D3 Receives: Dietary Supplement: Vitamin D3 |
| Vitamin E | Experimental | Daily dose of 100 mg Vitamin E Receives: Dietary Supplement: Vitamin E |
| Placebo | Placebo comparator | Daily dose of 575 mg microcrystalline cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
Measured: from baseline to 4 weeks
Secondary outcomes (5)
Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of alpha diversity assessed with shotgun sequencing (Shannon diversity, Estimated ChaoI index)
Measured: from baseline to 4 weeks
Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics)
Measured: from baseline to 4 weeks
Short-chain fatty acids concentrations in fecal samples
Changes from baseline in the treatment groups as compared to placebo of short-chain fatty acids using GC-MS (mM)
Measured: from baseline to 4 weeks
Ammonia concentrations in fecal samples
Changes from baseline in the treatment groups as compared to placebo of ammonia concentrations assessed with phenol-hypochlorite method (mg/L)
Measured: from baseline to 4 weeks
Cytokines and chemokines in blood
Changes from baseline in the treatment group as compared to placebo of cytokines and chemokines using immune assays (pg/mL)
Measured: from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start20 Aug 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
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 Healthy VolunteersStudies 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
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Prof, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668964
- Sponsor's protocol ID
- 2017-12-19-VIT
- Acronym
- VitaGut
- Status last verified
- Mar 2020
- First submitted
- 2 May 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pham VT, Fehlbaum S, Seifert N, Richard N, Bruins MJ, Sybesma W, Rehman A, Steinert RE. Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study. Gut Microbes. 2021 Jan-Dec;13(1):1-20. doi: 10.1080/19490976.2021.1875774.
PubMed 33615992
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
- ClinicalTrials.gov ID
- NCT03668964
- Acronym / sponsor ID
- VitaGut / 2017-12-19-VIT
- Conditions
- Healthy Volunteers
- Keywords
- Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 13 Sep 2018 (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 objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Randomized, double-blind, placebo-controlled, parallel trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin B2 | Experimental | Dietary Supplement: Vitamin B2Daily dose of 75 mg Vitamin B2 |
| Vitamin C | Experimental | Dietary Supplement: Vitamin CDaily dose of 500 mg Vitamin C |
| Vitamin B2 + C | Experimental | Dietary Supplement: Vitamin B2 + CDaily dose of 75 mg Vitamin B2 and 500 mg Vitamin C |
| Vitamin A | Experimental | Dietary Supplement: Vitamin ADaily dose of 250 µg Vitamin A |
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Daily dose of 60 µg Vitamin D3 |
| Vitamin E | Experimental | Dietary Supplement: Vitamin EDaily dose of 100 mg Vitamin E |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily dose of 575 mg microcrystalline cellulose |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
- Be between 20 and 50 years of age;
- Has a BMI of between 18.5 - 30 Kg/m2;
- Has a stable body weight (< 5% change) over the past 3-months;
- Is in general good health, as determined by the investigator;
Key exclusion criteria (21 listed)
- Females are pregnant, lactating or wish to become pregnant during the study.
- Are hypersensitive to any of the components of the test product;
- Has taken antibiotics within the previous 3 months;
- Has a history of drug and/or alcohol abuse at the time of enrolment;
- Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
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 |
|---|---|---|
| Vitamin B2Also: RiboflavinOne capsule of 75 mg Vitamin B2 once a day for 4 weeks | Dietary supplement | Vitamin B2 |
| Vitamin COne capsule of 500 mg Vitamin C once a day for 4 weeks | Dietary supplement | Vitamin C |
| Vitamin B2 + COne capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks | Dietary supplement | Vitamin B2 + C |
| Vitamin AOne capsule of 250 µg Vitamin A once a day for 4 weeks | Dietary supplement | Vitamin A |
| Vitamin D3Also: CholecalciferolOne capsule of 60 µg Vitamin D3 once a day for 4 weeks | Dietary supplement | Vitamin D3 |
| Vitamin EAlso: alpha-tocopherolOne capsule of 100 mg Vitamin E once a day for 4 weeks | Dietary supplement | Vitamin E |
| PlaceboOne capsule of 575 mg microcrystalline cellulose once a day for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
5 secondary outcomes
Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time frame: from baseline to 4 weeks
Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time frame: from baseline to 4 weeks
Short-chain fatty acids concentrations in fecal samples
Time frame: from baseline to 4 weeks
Ammonia concentrations in fecal samples
Time frame: from baseline to 4 weeks
Cytokines and chemokines in blood
Time frame: from baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 33615992Pham VT, Fehlbaum S, Seifert N, Richard N, Bruins MJ, Sybesma W, Rehman A, Steinert RE. Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study. Gut Microbes. 2021 Jan-Dec;13(1):1-20. doi: 10.1080/19490976.2021.1875774.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Timothy Dinan, Prof principal investigator
Cork University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B2, Vitamin C and Vitamin B2 + C in people with Healthy Volunteers, run by dsm-firmenich Switzerland AG at 1 site in Ireland.
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 10 inclusion and 21 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: finished, as of the sponsor's last update on 30 Mar 2020. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing (time frame: from baseline to 4 weeks). 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 NCT03668964, 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 30 Mar 2020.