Actively Recruiting
Benefit of Colon-delivered Riboflavin vs. Conventional Riboflavin on Gut Microbiota and Metabolic Output in Healthy Adults Aged 50-70
Led by dsm-firmenich Switzerland AG · Updated on 2026-03-19
90
Participants Needed
1
Research Sites
4 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
Researchers are studying the effects of colon-delivered vitamin B2 (riboflavin) compared to conventional riboflavin and a placebo in healthy adults aged 50 to 70. This study aims to understand how these forms affect gut microbiota, metabolic activity, and overall gut health, especially in an aging population. The trial explores potential benefits of riboflavin that reaches the colon versus forms absorbed earlier in the digestive tract. Participants will be randomly assigned to one of three groups: one taking 10 mg of colon-delivered riboflavin, another taking 10 mg of conventional riboflavin absorbed in the upper small intestine, or a placebo group receiving 10 mg of microcrystalline cellulose. The study includes an 8-week period of daily supplementation, with the last 4 weeks including an additional 5 g of dietary fiber inulin to the daily diet. Throughout the study, participants will undergo evaluations of gut microbial diversity, composition, and metabolic markers such as fecal organic acids, riboflavin levels, pH, and calprotectin. Assessments also include gastrointestinal symptoms, stool consistency and frequency, quality of life, and perceived benefit. These measures will help determine the impact of the different riboflavin forms on gut health. The study began in July 2025 and will continue until September 2026.
CONDITIONS
Brief 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 at V1 (indigestion, constipation, or diarrhoea score 3-5)
- Individuals with general good health based on questioning, clinical exam, and vital signs at V1
- Willing to avoid gut microbiome modulating supplements during the entire study
- Willing to maintain current level of physical activity throughout the study
- If taking chronic medications, must maintain same dosage throughout the study
You will not qualify if you...
- Hypersensitivity or intolerance to study product components or the standardized diet addition (inulin)
- Taken systemic antibiotics within 3 months prior to baseline or expected during study
- Consumed microbiome modulating supplements within 4 weeks prior to baseline
- Regular use of systemic steroids, proton pump inhibitors, H2 blockers, antacids (sporadic use allowed with restrictions), recent metformin start, or immunosuppressants
- History of drug or alcohol abuse in the last 5 years or current treatment for such
- Current smoker or vaper
- Vegetarian or vegan diet
- Major dietary changes in past 3 months prior to baseline
- Planned major lifestyle changes during the study
- Active eating disorder
- Self-reported food allergy or intolerance
- Clinically significant abnormal laboratory tests at screening
- Self-reported fibre-rich regular diet
- Gastrointestinal disorders or surgeries impacting outcomes
- GSRS scores >5 in any category at screening
- Severe or uncontrolled conditions impacting outcomes
- History of gastrointestinal cancer
- Severe immunocompromise
- Alarm symptoms like unintentional weight loss, fever, anorectal problems, blood in stool, vomiting in past 3 months
- Considered poor attendees or unlikely to comply with study requirements
- Participation in recent experimental study within 30 days prior to this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks of daily consumption
Participants consume 10 mg of colon-delivered riboflavin, conventional riboflavin, or placebo daily. From week 4 to week 8, a standardized addition of 5 g of dietary fiber inulin per day is included in their diet.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
analyze & realize GmbH
Berlin, State of Berlin, Germany, 10369
Actively Recruiting
Research Team
V
Veronika Bobb, Dr.
L
Liana Vismane, Dr
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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