Colon-delivered Riboflavin and Gut Microbiota Composition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
Sponsordsm-firmenich Switzerland AG
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Colon-delivered riboflavin
- Conventional riboflavin
- Microcrystalline Cellulose
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
dsm-firmenich Switzerland AG
Lead sponsor
Analyze & Realize
Collaborator
Source ClinicalTrials.gov