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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
90
10 mg of colon-delivered riboflavin
10 mg of conventional riboflavin
10 mg microcrystalline cellulose
analyze & realize GmbH
Berlin, State of Berlin, Germany
RECRUITINGMicrobial 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)
Microbial alpha diversity
Variation D56 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Microbial composition
Variations D28 - D0 and D56 - D0 in faecal microbial composition, assessed in terms of relative abundance of components at phylum, family, genus and species level and beta diversity (including Jaccard and Bray- Curtis dissimilarity indices)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Faecal organic acid
Variations D28 - D0 and D56 - D0 in faecal organic acid levels (acetate, propionate, butyrate, valerate, lactate)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Faecal riboflavin
Variations D28 - D0 and D56 - D0 in faecal concentrations of riboflavin
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
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Fecal redox potential
Variations D28 - D0 and D56 - D0 in fecal redox potential level
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
fecal pH
Variations D28 - D0 and D56 - D0 in fecal pH
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Fecal calprotectin
Variations D28 - D0 and D56 - D0 in fecal calprotectin
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Plasma Intestinal barrier markers
Variations D28 - D0 and D56 - D0 in plasma intestinal barrier markers (LBP, I-FABP, zonulin and DAO)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Gastrointestinal complaints
Variations D28 - D0 and D56 - D0 in gastrointestinal complaints assessed by the gastrointestinal Symptom Rating Scale (GSRS) (reflux, abdominal pain, indigestion, diarrhoea, constipation)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Stool consistency and frequency
Variations D28 - D0 and D56 - D0 in stool consistency as assessed by Bristol Stool Form Scale (BSFS) and frequency
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Quality of life (Short-Form Health Survey (SF-36))
Variations D28 - D0 and D56 - D0 in quality of life as assessed by the Short-Form Health Survey (SF-36)
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.
Investigational product (IP) perceived benefit
Variations D28 - D0 and D56 - D0 in Investigational product (IP) perceived benefit assessed by a by a 5 point Likert scale
Time frame: 8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.