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The purpose of this trial is to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces of healthy volunteers. Additionally it will be assessed whether riboflavin supplementation affects the abundance of potentially pathogenic bacteria such as adherent invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the production of Short Chain Fatty Acids, the release of gut hormones and potential changes in glucose homeostasis and appetite perception will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riboflavin Dose 1 | Experimental | 100 mg Riboflavin (one capsule) per day for 2 weeks |
|
| Riboflavin Dose 2 | Experimental | 50 mg Riboflavin (one capsule) per day for 2 weeks |
|
| Placebo | Placebo Comparator | 100 mg starch plus 0,5% silica (one capsule) per day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin Dose 1 | Dietary Supplement |
|
| |
| Riboflavin Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of F. prausnitzii per gram faeces | To determine the effect of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on the number of F. prausnitzii per gram faeces in comparison with placebo | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial composition (diversity and quantity of anaerobic microbiota) per gram faeces | To determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on bacterial composition (diversity and quantity of anaerobic microbiota) in comparison with placebo | 2 weeks |
| Production of short chain fatty acids (SCFA) in faeces |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hermie J.M. Harmsen, PhD | Medical Microbiology UMCG Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Microbiology, UMCG Groningen | Groningen | 9713 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943883 | Derived | Liu L, Sadaghian Sadabad M, Gabarrini G, Lisotto P, von Martels JZH, Wardill HR, Dijkstra G, Steinert RE, Harmsen HJM. Riboflavin Supplementation Promotes Butyrate Production in the Absence of Gross Compositional Changes in the Gut Microbiota. Antioxid Redox Signal. 2023 Feb;38(4-6):282-297. doi: 10.1089/ars.2022.0033. Epub 2022 Oct 10. |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Dietary Supplement |
|
|
| Placebo | Other |
|
To determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on the production of short chain fatty acids (SCFA) in faeces in comparison with placebo |
| 2 weeks |
| Gastrointestinal (GI) comfort (bloating, flatulence) | To determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on gastrointestinal (GI) comfort (bloating, flatulence) in comparison with placebo using validated visual analogue scale (VAS) questionnaires | 2 weeks |
| Oral Glucose Tolerance Test: blood glucose | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Oral Glucose Tolerance Test: plasma insulin | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Oral Glucose Tolerance Test: Glucagon-like Peptide 1 (GLP-1) | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Oral Glucose Tolerance Test: Glucagon-like Peptide 2 (GLP-2) | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Oral Glucose Tolerance Test: ghrelin | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Oral Glucose Tolerance Test: Appetite feelings during the test | In a subgroup of participants, to determine the effects of 2 weeks oral riboflavin supplementation (50 and 100 mg/day) on blood glucose, and plasma insulin, GLP-1, GLP-2 and ghrelin as well as appetite feelings during an oral glucose tolerance test (oGTT) in comparison with placebo | 2 weeks |
| Changes in stool characteristics: faeces pH | To determine the possible changes in stool characteristics such as faeces pH upon riboflavin supplementation | 2 weeks |
| Changes in stool characteristics: dry weight | To determine the possible changes in stool characteristics such as dry weight upon riboflavin supplementation | 2 weeks |
| Changes in gut permeability related biomarkers: fatty-acid-binding proteins (I-FABP (plasma)) | To determine any possible effect on gut permeability, assessment of permeability related biomarkers: fatty-acid-binding proteins (I-FABP (plasma)) and SM-22 (serum) upon riboflavin supplementation | 2 weeks |
| Changes in gut permeability related biomarkers: SM-22 (serum) | To determine any possible effect on gut permeability, assessment of permeability related biomarkers: fatty-acid-binding proteins (I-FABP (plasma)) and SM-22 (serum) upon riboflavin supplementation | 2 weeks |
| Riboflavin concentration in faeces | To determine the effects of 2 weeks oral riboflavin supplementation on riboflavin concentration in faeces and plasma | 2 weeks |
| Riboflavin concentration in plasma | To determine the effects of 2 weeks oral riboflavin supplementation on riboflavin concentration in faeces and plasma | 2 weeks |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |