Colon-delivered Riboflavin and Gut Microbiota Composition

NCT07093463 | Recruiting DMC

• 2 other identifiers: DSM/230702DSM/011224
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms. The present study explores the benefit of colon-delivered vitamin B2 vs. conventional vitamin B2 in comparison to placebo in an aging population on gut microbiota and metabolic activity as well as gut health.

Conditions

Microbiome Dysbiosis; Gut Health

Keywords

elderly; microbiome; colon delivered b-vitamins; riboflavin

Outcome Measures

Primary Outcomes (1)

• Microbial alpha diversity

  Variation D28 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index)

  4 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd)

Secondary Outcomes (12)

• Microbial alpha diversity

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

• Microbial composition

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

• Faecal organic acid

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

• Faecal riboflavin

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

• Fecal redox potential

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

Other Outcomes (2)

• Plasma riboflavin concentrations

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

• Plasma immune markers

  8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.

Study Arms (3)

Colon-delivered riboflavin

ACTIVE COMPARATOR

This arm includes 10 mg of colon-delivered riboflavin

Dietary Supplement: Colon-delivered riboflavin

Conventional riboflavin

ACTIVE COMPARATOR

This arm includes 10 mg of conventional riboflavin that will be absorbed in the upper small intestine and not reach the colon

Dietary Supplement: Conventional riboflavin

Placebo

PLACEBO COMPARATOR

This arm includes 10 mg of microcrystalline cellulose

Other: Microcrystalline Cellulose

Interventions

Colon-delivered riboflavin DIETARY_SUPPLEMENT

10 mg of colon-delivered riboflavin

Colon-delivered riboflavin

Conventional riboflavin DIETARY_SUPPLEMENT

10 mg of conventional riboflavin

Conventional riboflavin

Microcrystalline Cellulose OTHER

10 mg microcrystalline cellulose

Placebo

Eligibility Criteria

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

You may qualify if:

• Individuals providing written informed consent for participation in the study and data processing
• Female and males between 50 and 70 years of age
• For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding
• Individuals with a BMI between 18.5 - 29.9 Kg/m2
• Individuals with stable body weight (≤5% change) over the past 3 months prior to V1
• Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1
• Individuals with GSRS score suggestive of moderate bowel complaints, as assessed at V1, for the average condition over the 4 last weeks (all GSRS items have to be answered at V1): • indigestion score 3-5 or constipation score 3-5 or diarrhoea score 3-5
• Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1
• Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration
• Individuals willing to maintain current level of physical activity throughout the entire study duration
• If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study

You may not qualify if:

• Individuals who are hypersensitive/intolerant to any of the components of the Investigational product or the standardised diet addition (inulin)
• Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study
• Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2)
• Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study if needed is allowed, but not within 8 hours before each visit), metformin if started less than 6 months prior to V1, or immunosuppressant medication.
• Individuals who have a history of drug abuse in the previous 5 years and/or alcohol abuse at the time of enrolment (\>11 units/week for women; \>17 units/week for men; unit: approx. 125 mL of wine or similar / approx. 30 mL of spirits
• / approx. 280 mL beer or similar); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder)
• Individuals who are a smoker or vaper
• Individuals who are vegetarian or vegan
• Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)
• Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
• Individuals who have a currently present active eating disorder
• Individuals with self-reported food allergy / intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator
• Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement
• Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement
• Individuals who have a (self-reported) gastrointestinal disorder/disease (e.g., chronic/recurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid malabsorption) or previous gastrointestinal surgery (such as bariatric surgery, colon specific surgical interventions etc.), which in the opinion of the investigator would impact the study outcomes

Sponsors & Collaborators

• Analyze & Realize: collaborator
• dsm-firmenich Switzerland AG: lead

Study Sites (1)

analyze & realize GmbH

Berlin, State of Berlin, 10369, Germany

RECRUITING

MeSH Terms

Interventions

microcrystalline cellulose

Central Study Contacts

Veronika Bobb, Dr.

CONTACT

+49 30 4000 8152; vbobb@a-r.com

Liana Vismane, Dr

CONTACT

+49 30 4000 8152; lvismane@a-r.com

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

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

DE (1)