Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation

Nathalie Delzenne1 site in 1 country17 target enrollmentApril 22, 2018

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Nathalie Delzenne
Enrollment: 17
Locations: 1
Primary Endpoint: Gut microbiota composition
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.

Registry

clinicaltrials.gov

Start Date

April 22, 2018

End Date

May 18, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nathalie Delzenne

Responsible Party

Sponsor Investigator

Principal Investigator

Nathalie Delzenne

Professor

Université Catholique de Louvain

Eligibility Criteria

Inclusion Criteria

•Woman or man, aged of 18 to 40 years
•Body mass index (BMI) between 18 and 25 kg/m2
•In good general health as evidenced by medical history and physical examination
•Non-smoker
•Caucasian
•H2 - producer
•Provision of signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

•Subjects presenting gastro-intestinal disorders such as ulcers, diverticulitis and inflammatory bowel diseases
•Subject presenting allergy or food intolerance (lactose, gluten,...)
•Subjects with psychiatric problems and/or using antipsychotics
•Current or recent (\< 4 weeks) intake of antibiotic, probiotic, prebiotic, fiber supplement, and/or any product modulating gut transit
•Feeding particular diet such as vegetarian diet or hyper protein diet
•Chronic intake of drug, excepted contraceptive drug
•Pregnant or lactating woman or woman who did not use highly effective contraception
•Subjects who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day)
•Subjects having participated to another clinical trial two weeks before the screening test visit
•Subjects presenting an allergy or intolerance to one component of the product tested

Outcomes

Primary Outcomes

Gut microbiota composition

Time Frame: Difference between day 0 and day 21

Illumina sequencing of 16SrDNA

Secondary Outcomes

Fecal short-chain fatty acids(Difference between day 0 and day 21)
Fecal bile acids(Difference between day 0 and day 21)
Exhaled acetate(Difference between day 0 and day 21)
Fecal conjugated-linoleic acids(Difference between day 0 and day 21)
Exhaled propionate(Difference between day 0 and day 21)
Exhaled H2S(Difference between day 0 and day 21)
Exhaled CH4(Difference between day 0 and day 21)
Exhaled H2(Difference between day 0 and day 21)
Gastro-intestinal symptom - nausea(Difference between Day 0 and Day 21)
Exhaled butyrate(Difference between day 0 and day 21)
Exhaled C2(Difference between day 0 and day 21)
Exhaled CO2(Difference between day 0 and day 21)
Exhaled O2(Difference between day 0 and day 21)
Exhaled CO(Difference between day 0 and day 21)
Gastro-intestinal symptom - flatulences(Difference between Day 0 and Day 21)
Gastro-intestinal symptom - gastrointestinal reflux(Difference between Day 0 and Day 21)
Exhaled N2(Difference between day 0 and day 21)
Exhaled volatile compounds(Difference between day 0 and day 21)
Gastro-intestinal symptom - discomfort(Difference between Day 0 and Day 21)
Gastro-intestinal symptom - cramps(Difference between Day 0 and Day 21)
Gastro-intestinal symptom - rumbling(Difference between Day 0 and Day 21)
Gastro-intestinal symptom - burps(Difference between Day 0 and Day 21)
Gastro-intestinal symptom - bloating(Difference between Day 0 and Day 21)