Actively Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Led by dsm-firmenich Switzerland AG · Updated on 2026-03-19
90
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
D
dsm-firmenich Switzerland AG
Lead Sponsor
A
Analyze & Realize
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Colon-delivered Riboflavin and Gut Microbiota Composition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 (sporadic use allowed but not within 8 hours before visits), metformin if started less than 6 months prior to V1, or immunosuppressant medication
- Individuals with recent history of drug or alcohol abuse or currently in treatment for substance abuse
- Individuals who are smokers or vapers
- Individuals who are vegetarian or vegan
- Individuals who have made major dietary changes in the past 3 months prior to Baseline (V2)
- Individuals planning major lifestyle changes during the study
- Individuals with active eating disorders
- Individuals with self-reported food allergies or intolerances
- Individuals with clinically significant abnormal blood test results at screening
- Individuals with self-reported fibre-rich regular diet
- Individuals with gastrointestinal disorders or previous gastrointestinal surgery affecting study outcomes
- Individuals with GSRS scores above 5 for any symptom at screening
- Individuals with severe or uncontrolled medical conditions such as type 2 diabetes, psychiatric, respiratory, or cardiac illnesses
- Individuals with a history of gastrointestinal cancer
- Severely immunocompromised individuals
- Individuals with alarm symptoms such as significant weight loss, fever, anorectal problems, blood in stool, or vomiting in the past 3 months
- Individuals considered unlikely to comply with study requirements
- Individuals who participated in another experimental study within 30 days prior to this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
analyze & realize GmbH
Berlin, State of Berlin, Germany, 10369
Actively Recruiting
Research Team
V
Veronika Bobb, Dr.
CONTACT
L
Liana Vismane, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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