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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Colon-delivered riboflavin
Dietary supplement
10 mg of colon-delivered riboflavin
Conventional riboflavin
Dietary supplement
10 mg of conventional riboflavin
Microcrystalline Cellulose
Other intervention
10 mg microcrystalline cellulose

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Colon-delivered riboflavinActive comparator 1 intervention

Group B: Conventional riboflavinActive comparator 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Microbial alpha diversity

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

Time frame

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

Secondary outcomes

1

Microbial alpha diversity

Variation D56 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index)

Time frame