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

Sponsor
DSM Nutritional Products, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05803811
Collaborator
Atlantia Food Clinical Trials (Industry)
348
1
4
8.7
39.8

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Riboflavin
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
348 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled, parallel trialRandomized, double-blind, placebo-controlled, parallel trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
May 29, 2023
Anticipated Study Completion Date :
Sep 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low dose

Daily dose of 1.4 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks

Dietary Supplement: Riboflavin
Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Experimental: Mid dose

Daily dose of 10 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks

Dietary Supplement: Riboflavin
Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Experimental: high dose

Daily dose of 75 mg Vitamin B2 (Riboflavin) once a day for 12 weeks

Dietary Supplement: Riboflavin
Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Placebo Comparator: Placebo

One capsule of 570 mg (consisting of microcrystalline cellulose) once a day for 12 weeks

Dietary Supplement: Riboflavin
Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Faecal microbial composition and diversity [from baseline to 12 weeks]

    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

Secondary Outcome Measures

  1. Faecal microbial metabolites fatty acid content at baseline and week 12 [Intestinal inflammation as assessed by faecal calprotectin at baseline and at week 12]

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

  2. Intestinal inflammation [from baseline to 12 weeks]

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

  3. Intestinal barrier integrity [from baseline to 12 weeks]

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

  4. Oxidative stress in blood [from baseline to 12 weeks]

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

  5. Inflammatory status in blood [from baseline to 12 weeks]

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

  6. Gastrointestinal symptoms [from baseline to 12 weeks]

    Gastrointestinal symptoms as assesed by Gastrointestinal Symptom Rating Scale (GSRS) at baseline and at week 12.

  7. health-related quality of life [from baseline to 12 weeks]

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

  8. Stool consistency [from baseline to 12 weeks]

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

  9. Stool frequency [from baseline to 12 weeks]

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

  10. Systemic vitamin status [from baseline to 12 weeks]

    The concentration of B vitamins in blood at baseline

  11. Faecal physiological pH [from baseline to 12 weeks]

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

  12. Faecal microbial composition and diversity at week 4 [from baseline to 4 weeks]

    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.

  13. Microbial metabolites at week 4 [from baseline to 12 weeks]

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

Other Outcome Measures

  1. Skin barrier integrity [from baseline to 12 weeks]

    Skin barrier integrity measured as trans-epidermal water loss (TEWL) g/m²/h at baseline and at week 12.

  2. Skin hydration [from baseline to 12 weeks]

    Skin hydration measured using corneometry from 0 (no water at all) to 120 (on water) at baseline and at week 12.

  3. Objective skin-health [from baseline to 12 weeks]

    Objective skin-health assessment completed by the participant using Likert scale (from not at al to very much) at baseline and at week 12.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.

  2. Between 50 and 70 years of age.

  3. Has a BMI of between 18.5 - 30 Kg/m2.

  4. Participants have had a stable body weight (≤5 % change) over the past 3-months.

  5. Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.

  6. 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.

  7. Maintain current level of physical activity.

  8. Willing to consume the investigational product daily for the duration of the study.

  9. Female participants in menopause for at least the last one year. -

Exclusion Criteria:
  1. Are hypersensitive to any of the components of the test product.

  2. Has taken antibiotics within the previous 3 months prior to Baseline (Visit2)

  3. Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.

  4. 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).

  5. Is a smoker or vaper.

  6. Vegetarian or vegan.

  7. Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).

  8. Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.

  9. Has a currently active eating disorder.

  10. Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.

  11. Is having a typical fibre intake >30 g fibre/day.

  12. Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.

  13. 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.

  14. 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.

  15. Has a current or history of any gastrointestinal cancer

  16. 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).

  17. Experiences alarm features such as weight loss, rectal bleeding, a recent change in bowel habit (<3 months).

  18. Have a current malignant disease or any concomitant end-stage organ disease.

  19. 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.

  20. 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.

  21. Participants who have undergone intensive skin treatments (e.g. laser treatment or skin related surgery) in the last 3 months.

  22. 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).

  23. Has a skin condition likely to interfere with skin assessments (e.g., eczema, dermatitis, any open skin wounds, reactive and sensitive skin).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork Cork Ireland

Sponsors and Collaborators

  • DSM Nutritional Products, Inc.
  • Atlantia Food Clinical Trials

Investigators

  • Principal Investigator: Prof Timothy Dinan, Cork University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT05803811
Other Study ID Numbers:
  • 2020-11-11-VITB2
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DSM Nutritional Products, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023