Gut Health, Microbiome Dysbiosis
Conditions
Keywords
elderly, microbiome, colon delivered b-vitamins, riboflavin
Brief 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.
Interventions
DIETARY_SUPPLEMENTColon-delivered riboflavin
10 mg of colon-delivered riboflavin
DIETARY_SUPPLEMENTConventional riboflavin
10 mg of conventional riboflavin
OTHERMicrocrystalline Cellulose
10 mg microcrystalline cellulose
Sponsors
dsm-firmenich Switzerland AG
Analyze & Realize
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals providing written informed consent for participation in the study and data processing 2. Female and males between 50 and 70 years of age 3. For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding 4. Individuals with a BMI between 18.5 - 29.9 Kg/m2 5. Individuals with stable body weight (≤5% change) over the past 3 months prior to V1 6. Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1 7. 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 8. Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1 9. Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration 10. Individuals willing to maintain current level of physical activity throughout the entire study duration 11. If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study
Exclusion criteria
1. Individuals who are hypersensitive/intolerant to any of the components of the Investigational product or the standardised diet addition (inulin) 2. 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 3. Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2) 4. 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. 5. 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 / approx. 280 mL beer or similar); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder) 6. Individuals who are a smoker or vaper 7. Individuals who are vegetarian or vegan 8. Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2) 9. Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study. 10. Individuals who have a currently present active eating disorder 11. Individuals with self-reported food allergy / intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator 12. Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement 13. Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement 14. Individuals who have a (self-reported) gastrointestinal disorder/disease (e.g., chronic/recurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid malabsorption) or previous gastrointestinal surgery (such as bariatric surgery, colon specific surgical interventions etc.), which in the opinion of the investigator would impact the study outcomes 15. Individuals with GSRS assessed at V1 for the average condition over the 4 last weeks prior to V1 for any score (abdominal pain, reflux score, indigestion, constipation, diarrhoea) \>5 (all GSRS items have to be answered at V1) 16. Individuals who have severe or uncontrolled conditions such as type 2 diabetes (FBG ≥ 150 mg/dl from blood draw at V1), psychiatric disorder, respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes 17. Individuals who have a history of any gastrointestinal cancer 18. Individuals who are severely immunocompromised 19. Individuals with alarm features in the past 3 months prior to V1 such as unintentional weight loss (≤5% change), fever, anorectal problems, blood in stool, vomiting 20. Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the study requirements 21. If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial alpha diversity | 4 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) | Variation D28 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal complaints | 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. | Variations D28 - D0 and D56 - D0 in gastrointestinal complaints assessed by the gastrointestinal Symptom Rating Scale (GSRS) (reflux, abdominal pain, indigestion, diarrhoea, constipation) |
| Stool consistency and frequency | 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. | Variations D28 - D0 and D56 - D0 in stool consistency as assessed by Bristol Stool Form Scale (BSFS) and frequency |
| Microbial alpha diversity | 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. | Variation D56 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index) |
| Microbial composition | 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. | 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) |
| Faecal organic acid | 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. | Variations D28 - D0 and D56 - D0 in faecal organic acid levels (acetate, propionate, butyrate, valerate, lactate) |
| Faecal riboflavin | 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. | Variations D28 - D0 and D56 - D0 in faecal concentrations of riboflavin |
| Fecal redox potential | 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. | Variations D28 - D0 and D56 - D0 in fecal redox potential level |
| fecal pH | 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. | Variations D28 - D0 and D56 - D0 in fecal pH |
| Fecal calprotectin | 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. | Variations D28 - D0 and D56 - D0 in fecal calprotectin |
| Quality of life (Short-Form Health Survey (SF-36)) | 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. | Variations D28 - D0 and D56 - D0 in quality of life as assessed by the Short-Form Health Survey (SF-36) |
| Plasma Intestinal barrier markers | 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. | Variations D28 - D0 and D56 - D0 in plasma intestinal barrier markers (LBP, I-FABP, zonulin and DAO) |
| Investigational product (IP) perceived benefit | 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. | Variations D28 - D0 and D56 - D0 in Investigational product (IP) perceived benefit assessed by a by a 5 point Likert scale |
Countries
Germany
Contacts
CONTACTVeronika Bobb, Dr.
CONTACTLiana Vismane, Dr
Outcome results
None listed