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Quality of LifeNCT05803811

Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults

A study testing Riboflavin in people with Quality of Life, run by dsm-firmenich Switzerland AG at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age) Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Quality of Life
What is being tested?
Riboflavin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
1 siteIreland
Study dates
12 Dec 2022to 6 Jul 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 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.
  • Between 50 and 70 years of age.
  • Has a BMI of between 18.5 - 30 Kg/m2.
  • Participants have had a stable body weight (≤5 % change) over the past 3-months.
  • Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.
  • Willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements, and, within 4 weeks prior to the baseline visit, until the end of the study.
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  • Maintain current level of physical activity.
  • Willing to consume the investigational product daily for the duration of the study.
  • Female participants in menopause for at least the last one year. -

Who cannot join

  • Are hypersensitive to any of the components of the test product.
  • Has taken antibiotics within the previous 3 months prior to Baseline (Visit2)
  • Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.
  • Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder).
  • Is a smoker or vaper.
  • Vegetarian or vegan.
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  • Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).
  • Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
  • Has a currently active eating disorder.
  • Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.
  • Is having a typical fibre intake >30 g fibre/day.
  • Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.
  • If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months to screening and agree to maintain the same dosage throughout the study.
  • Has severe or uncontrolled type 2 diabetes, psychiatric disorder, gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes.
  • Has a current or history of any gastrointestinal cancer
  • Are severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy with the last year).
  • Experiences alarm features such as weight loss, rectal bleeding, a recent change in bowel habit (<3 months).
  • Have a current 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.
  • Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
  • Participants who have undergone intensive skin treatments (e.g. laser treatment or skin related surgery) in the last 3 months.
  • If taking any dietary supplements or medications known to affect skin health or other trial measures (resveratrol, ginkgo biloba, ginseng, fruit powder extracts and DHA).
  • Has a skin condition likely to interfere with skin assessments (e.g., eczema, dermatitis, any open skin wounds, reactive and sensitive skin).
  • -

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork

    Cork

Other trials in Ireland

About this study

The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age)

Conditions
Quality of Life
Being tested
Riboflavin
Keywords
microbiota, vitaminB2, Riboflavin, ShortChain fatty acids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RiboflavinDietary supplement

    Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Study groups in NCT05803811
Study groupRoleWhat they receive
Low doseExperimentalDaily dose of 1.4 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Receives: Dietary Supplement: Riboflavin
Mid doseExperimentalDaily dose of 10 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Receives: Dietary Supplement: Riboflavin
high doseExperimentalDaily dose of 75 mg Vitamin B2 (Riboflavin) once a day for 12 weeks
Receives: Dietary Supplement: Riboflavin
PlaceboPlacebo comparatorOne capsule of 570 mg (consisting of microcrystalline cellulose) once a day for 12 weeks
Receives: Dietary Supplement: Riboflavin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Faecal microbial composition and diversity

    To assess the changes of faecal microbial composition and diversity from baseline to 12 weeks supplementation of three different doses of colon delivered vitamin B2 to compare the changes to placebo. levels, and alpha and beta diversity indices at the genus and species level as measured by metagenomic based profiles at baseline and at week 12

    Measured: from baseline to 12 weeks

Secondary outcomes (13)

  1. Faecal microbial metabolites fatty acid content at baseline and week 12

    Faecal microbial metabolites measured as short-chain fatty acid content at baseline and week 12

    Measured: Intestinal inflammation as assessed by faecal calprotectin at baseline and at week 12

  2. Intestinal inflammation

    Intestinal barrier integrity as assessed by sCD14 at baseline and at week 12

    Measured: from baseline to 12 weeks

  3. Intestinal barrier integrity

    Oxidative stress level measured as free thiol content in blood at baseline and at week 12

    Measured: from baseline to 12 weeks

  4. Oxidative stress in blood

    Oxidative stress level measured as free thiol content in blood at baseline and at week 12

    Measured: from baseline to 12 weeks

  5. Inflammatory status in blood

    Systemic inflammation measured as high sensitive C reactive protein (hs-CRP) in blood at baseline and at week 12.

    Measured: from baseline to 12 weeks

  6. Gastrointestinal symptoms

    Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS).The GSRS is a 15 items questionnaire combined into five symptom clusters i.e Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.(GSRS) at baseline and at week 12.

    Measured: from baseline to 12 weeks

  7. health-related quality of life

    Quality of life as assessed by short form survey-36 (SF-36) questionnaires at baseline and at week 12.

    The SF-36 is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase.

    Measured: from baseline to 12 weeks

  8. Stool consistency

    Stool consistency (Bristol Stool Scale), as reported in the daily eDiary app (at baseline and week 12).

    Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass [classified as severe constipation]; Type 7 = watery, entirely liquid stool [classified as severe diarrhea]). 'Normal' stool is considered to be Types 3 and 4; and Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively.

    Measured: from baseline to 12 weeks

  9. Stool frequency

    Stool frequency, as reported in the daily eDiary app (at baseline and week 12).

    Measured: from baseline to 12 weeks

  10. Systemic vitamin status

    The concentration of B vitamins in blood at baseline

    Measured: from baseline to 12 weeks

  11. Faecal physiological pH

    Faecal physiological parameters measured as pH potential at baseline and at week 12.

    Measured: from baseline to 12 weeks

  12. Faecal microbial composition and diversity at week 4

    Faecal microbial composition at phylum, genus, and species levels, and alpha and beta diversity indices at the genus and species level as measured by metagenomic based profiles at baseline and at week 4.

    Measured: from baseline to 4 weeks

  13. Microbial metabolites at week 4

    Faecal microbial metabolites measured as short-chain fatty acid content at baseline and week 4.

    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.

  1. First posted7 Apr 2023
  2. Study start12 Dec 2022
  3. Primary completion6 Jul 2023
  4. Study completion6 Jul 2023

Resources

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
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803811
Sponsor's protocol ID
2020-11-11-VITB2
Status last verified
Sep 2023
First submitted
16 Feb 2023
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Riboflavin in people with Quality of Life, 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 9 inclusion and 24 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 17 Jan 2025. 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?

Faecal microbial composition and diversity (time frame: from baseline to 12 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 NCT05803811.

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 17 Jan 2025.

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