Colon-delivered Riboflavin and Gut Microbiota Composition (NCT07093463) | Clinical Trial Compass
RecruitingNot Applicable
Colon-delivered Riboflavin and Gut Microbiota Composition
Germany90 participantsStarted 2025-07-18
Plain-language 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.
Who can participate
Age range50 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Microbial alpha diversity
Timeframe: 4 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd)
✕. 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
✕. 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)