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

NCT05803811 | Completed DMC

• 1 other identifier: 2020-11-11-VITB2
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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)

Conditions

Quality of Life

Keywords

microbiota; vitaminB2; Riboflavin; ShortChain fatty acids

Outcome Measures

Primary Outcomes (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

  from baseline to 12 weeks

Secondary Outcomes (13)

• Faecal microbial metabolites fatty acid content at baseline and week 12

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

• Intestinal inflammation

  from baseline to 12 weeks

• Intestinal barrier integrity

  from baseline to 12 weeks

• Oxidative stress in blood

  from baseline to 12 weeks

• Inflammatory status in blood

  from baseline to 12 weeks

Other Outcomes (3)

• Skin barrier integrity

  from baseline to 12 weeks

• Skin hydration

  from baseline to 12 weeks

• Objective skin-health

  from baseline to 12 weeks

Study Arms (4)

Low dose

EXPERIMENTAL

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

Dietary Supplement: Riboflavin

Mid dose

EXPERIMENTAL

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

Dietary Supplement: Riboflavin

high dose

EXPERIMENTAL

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

Dietary Supplement: Riboflavin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Riboflavin

Interventions

Riboflavin DIETARY_SUPPLEMENT

Colon delivered vitamin B2 (Riboflavin) for 12 weeks

Low dose; Mid dose; Placebo; high dose

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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. -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

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

Cork, Ireland

Location

MeSH Terms

Interventions

Riboflavin

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Prof Timothy Dinan

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel trial

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 7, 2023
• Study Start: December 12, 2022
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: January 17, 2025

Record last verified: 2023-09

Locations

IE (1)