- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929459
Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota
January 20, 2020 updated by: DSM Nutritional Products, Inc.
Effects of Oral Riboflavin Supplementation on the Growth of Faecalibacterium Prausnitzii and the Impact on the Gut Microbiota: A Randomized, Double-blind, Placebo-controlled Human Intervention Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
105
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9713
- Medical Microbiology, UMCG Groningen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or Females, age 20 - 60 years
- Participant is willing to stick to his/her normal habitual diet excluding consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. throughout the study period
- Participant is willing to maintain his/her habitual physical activity patterns throughout the study period
- Participant has been stable in body-weight within the last 6 months
- Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results
- Participant has a body mass index (BMI) of ≥18.5 and ≤ 24.9 kg/m2 at screening
- Participant is willing to refrain from consuming alcoholic drinks 24 h prior to test days (V2 - V3)
- Participant is not smoking
- Participant is able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests
- Participant understands the study procedures and signs forms providing informed consent to participate in the study
Exclusion Criteria:
- Participant has abnormal clinical chemistry and haematology laboratory test results of clinical significance that in the judgment of the investigator would interfere with the participant's ability to comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk
- Participants with a history of GI disorders that are likely to interfere with the mode of action of the test product
- Participant has donated more than 300 mL of blood during the three months prior to screening
- Participant has a history, in the judgment of the investigator, of a psychological illness or condition such as to interfere with the participant's ability to understand the requirements of the study
- Use of antibiotics or signs of active systemic infection in the last 6 months
- Participants who are on hypocaloric/hypercaloric diet aiming for weight loss/gain
- Participant has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
- Participant is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation
- Regular use of dietary supplements e.g. riboflavin, fish oil, 1 month prior to study inclusion
- Participant has had exposure to any non-registered drug product within 30 days prior to the screening visit
- Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine)
- Participant has a known allergy or sensitivity to study product or any ingredients of the study product or meals provided
- Use of commercially available probiotic, prebiotic and other supplements that may affect the gut microbiota
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Riboflavin Dose 1
100 mg Riboflavin (one capsule) per day for 2 weeks
|
Other Names:
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Experimental: Riboflavin Dose 2
50 mg Riboflavin (one capsule) per day for 2 weeks
|
Other Names:
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Placebo Comparator: Placebo
100 mg starch plus 0,5% silica (one capsule) per day for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of F. prausnitzii per gram faeces
Time Frame: 2 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacterial composition (diversity and quantity of anaerobic microbiota) per gram faeces
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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)
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
To determine the possible changes in stool characteristics such as faeces pH upon riboflavin supplementation
|
2 weeks
|
Changes in stool characteristics: dry weight
Time Frame: 2 weeks
|
To determine the possible changes in stool characteristics such as dry weight upon riboflavin supplementation
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2 weeks
|
Changes in gut permeability related biomarkers: fatty-acid-binding proteins (I-FABP (plasma))
Time Frame: 2 weeks
|
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
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2 weeks
|
Changes in gut permeability related biomarkers: SM-22 (serum)
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
To determine the effects of 2 weeks oral riboflavin supplementation on riboflavin concentration in faeces and plasma
|
2 weeks
|
Riboflavin concentration in plasma
Time Frame: 2 weeks
|
To determine the effects of 2 weeks oral riboflavin supplementation on riboflavin concentration in faeces and plasma
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hermie J.M. Harmsen, PhD, Medical Microbiology UMCG Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiboGut2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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