Clinical trial NCT03505177: Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
Official title: Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Supplementation during 3 weeks with 4.5g of chitin-glucan
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Gut microbiota composition
timeFrame: Difference between day 0 and day 21
Secondary outcomes:
measure: Fecal short-chain fatty acids
timeFrame: Difference between day 0 and day 21
measure: Fecal bile acids
timeFrame: Difference between day 0 and day 21
measure: Fecal conjugated-linoleic acids
timeFrame: Difference between day 0 and day 21
measure: Exhaled acetate
timeFrame: Difference between day 0 and day 21
measure: Exhaled propionate
timeFrame: Difference between day 0 and day 21
measure: Exhaled butyrate
timeFrame: Difference between day 0 and day 21
measure: Exhaled C2
timeFrame: Difference between day 0 and day 21
measure: Exhaled CO2
timeFrame: Difference between day 0 and day 21
measure: Exhaled H2S
timeFrame: Difference between day 0 and day 21
measure: Exhaled O2
timeFrame: Difference between day 0 and day 21
measure: Exhaled N2
timeFrame: Difference between day 0 and day 21
measure: Exhaled CH4
timeFrame: Difference between day 0 and day 21
measure: Exhaled CO
timeFrame: Difference between day 0 and day 21
measure: Exhaled H2
timeFrame: Difference between day 0 and day 21
measure: Exhaled volatile compounds
timeFrame: Difference between day 0 and day 21
measure: Gastro-intestinal symptom - discomfort
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - nausea
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - bloating
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - flatulences
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - gastrointestinal reflux
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - cramps
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - rumbling
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - burps
timeFrame: 3 weeks
measure: Gastro-intestinal symptom - discomfort
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - nausea
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - bloating
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - flatulences
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - gastrointestinal reflux
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - cramps
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - rumbling
timeFrame: Difference between Day 0 and Day 21
measure: Gastro-intestinal symptom - burps
timeFrame: Difference between Day 0 and Day 21
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition
Study officials:
References: