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| ID | Type | Description | Link |
|---|---|---|---|
| DSM/011224 | Other Identifier | Cro |
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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colon-delivered riboflavin | Active Comparator | This arm includes 10 mg of colon-delivered riboflavin |
|
| Conventional riboflavin | Active Comparator | This arm includes 10 mg of conventional riboflavin that will be absorbed in the upper small intestine and not reach the colon |
|
| Placebo | Placebo Comparator | This arm includes 10 mg of microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon-delivered riboflavin | Dietary Supplement | 10 mg of colon-delivered riboflavin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial alpha diversity | Variation D28 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index) | 4 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial alpha diversity | Variation D56 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma riboflavin concentrations | Variations D28 - D0 and D56 - D0 in Plasma riboflavin concentrations | 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 immune markers |
Inclusion Criteria:
Exclusion Criteria:
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.
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)
Individuals who are a smoker or vaper
Individuals who are vegetarian or vegan
Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)
Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
Individuals who have a currently present active eating disorder
Individuals with self-reported food allergy / intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator
Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement
Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement
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
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)
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
Individuals who have a history of any gastrointestinal cancer
Individuals who are severely immunocompromised
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
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
If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronika Bobb, Dr. | Contact | +49 30 4000 8152 | vbobb@a-r.com | |
| Liana Vismane, Dr | Contact | +49 30 4000 8152 | lvismane@a-r.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Recruiting | Berlin | State of Berlin | 10369 | Germany |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Conventional riboflavin | Dietary Supplement | 10 mg of conventional riboflavin |
|
| Microcrystalline Cellulose | Other | 10 mg microcrystalline cellulose |
|
| 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) | 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) | 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 | 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 redox potential | Variations D28 - D0 and D56 - D0 in fecal redox potential level | 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 | 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 | 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) | 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) | 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 | 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) | 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 | 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 immune markers (IL-6, IL-10, TNF alpha) |
| 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. |