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CompletedNCT03668964VitaGutUpdated Mar 30, 2020

Effect of Nutrition Ingredients on Microbiota Modulation

An interventional study of Vitamin B2 and Vitamin C in Healthy Volunteers, sponsored by dsm-firmenich Switzerland AG. Completed at 1 site in Ireland. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by dsm-firmenich Switzerland AG (part of dsm-firmenich) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Intestinal microbiota
03

In context

Lead sponsor

dsm-firmenich Switzerland AG is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Browse dsm-firmenich Switzerland AG studies →All dsm-firmenich studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
  2. Be between 20 and 50 years of age;
  3. Has a BMI of between 18.5 - 30 Kg/m2;
  4. Has a stable body weight (\< 5% change) over the past 3-months;
  5. Is in general good health, as determined by the investigator;
  6. 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;
  7. Willing to avoid liver consumption during the intervention
  8. Maintain current level of physical activity;
  9. Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
  10. Willing to consume the investigational product daily for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Females are pregnant, lactating or wish to become pregnant during the study.
  2. Are hypersensitive to any of the components of the test product;
  3. Has taken antibiotics within the previous 3 months;
  4. Has a history of drug and/or alcohol abuse at the time of enrolment;
  5. Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
  6. Is a smoker;
  7. Has made any major dietary changes in the past 3 months;
  8. Subject is planning a sun or ski holiday over the duration of the study;
  9. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
  10. Has an eating disorder;
  11. Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
  12. Is using fibre supplements or enemas;
  13. Has a high fiber diet (i.e. >30 g) based on FFQ;
  14. Has an active gastrointestinal disorder or previous gastrointestinal surgery,
  15. 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;
  16. 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;
  17. Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
  18. Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (\<3 months) or abdominal pain;
  19. Have a malignant disease or any concomitant end-stage organ disease;
  20. 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;
  21. 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Vitamin B2

    Daily dose of 75 mg Vitamin B2

    Dietary Supplement: Vitamin B2

  • Experimental
    Vitamin C

    Daily dose of 500 mg Vitamin C

    Dietary Supplement: Vitamin C

  • Experimental
    Vitamin B2 + C

    Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C

    Dietary Supplement: Vitamin B2 + C

  • Experimental
    Vitamin A

    Daily dose of 250 µg Vitamin A

    Dietary Supplement: Vitamin A

  • Experimental
    Vitamin D3

    Daily dose of 60 µg Vitamin D3

    Dietary Supplement: Vitamin D3

  • Experimental
    Vitamin E

    Daily dose of 100 mg Vitamin E

    Dietary Supplement: Vitamin E

  • Placebo comparator
    Placebo

    Daily dose of 575 mg microcrystalline cellulose

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin B2

    One capsule of 75 mg Vitamin B2 once a day for 4 weeks

    Also known as: Riboflavin

  • Dietary supplementVitamin C

    One capsule of 500 mg Vitamin C once a day for 4 weeks

  • Dietary supplementVitamin B2 + C

    One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks

  • Dietary supplementVitamin A

    One capsule of 250 µg Vitamin A once a day for 4 weeks

  • Dietary supplementVitamin D3

    One capsule of 60 µg Vitamin D3 once a day for 4 weeks

    Also known as: Cholecalciferol

  • Dietary supplementVitamin E

    One capsule of 100 mg Vitamin E once a day for 4 weeks

    Also known as: alpha-tocopherol

  • Dietary supplementPlacebo

    One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: from baseline to 4 weeks

Secondary outcomes

  1. 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)

    Time frame: from baseline to 4 weeks

  2. 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)

    Time frame: from baseline to 4 weeks

  3. 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)

    Time frame: from baseline to 4 weeks

  4. 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)

    Time frame: from baseline to 4 weeks

  5. 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)

    Time frame: from baseline to 4 weeks

Other outcomes

  1. Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire

    Changes from baseline in the treatment groups as compared to placebo of the GSRS. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms

    Time frame: from baseline to 4 weeks

  2. Short Form 36 (SF-36) questionnaire

    Changes from baseline in the treatment groups as compared to placebo of the quality of life questionnaire Short Form 36 (SF-36) questionnaire. The Short Form (SF)-36 generates a profile of health-related quality of life outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0 to 100; where 100 indicates "good health".

    Time frame: from baseline to 4 weeks

  3. Volatile organic compound levels in fecal samples

    Changes from baseline in the treatment groups as compared to placebo of volatile organic compounds (intensity)

    Time frame: from baseline to 4 weeks

07

Study locations

1 site
  • Atlantia
    Cork, Blackpool Cork T12HH60, Ireland
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Jul 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2018
First posted
Sep 13, 2018
StartActual
Aug 20, 2018
Primary completionActual
Jul 15, 2019
CompletionActual
Jul 15, 2019
Last update
Mar 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03668964
Lead sponsor
dsm-firmenich Switzerland AG
Collaborators
Atlantia Food Clinical Trials
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Aug 20, 2018
Primary completion
Jul 15, 2019
Completion
Jul 15, 2019
Last update
Mar 30, 2020

Study contacts

Timothy Dinan, Prof
principal investigator · Cork University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Riboflavin · Ascorbic Acid · Vitamin A · Cholecalciferol · Vitamin E

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