Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Chitin-glucan fiber
- Registration Number
- NCT03505177
- Lead Sponsor
- Nathalie Delzenne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chitin-glucan Chitin-glucan fiber Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber
- Primary Outcome Measures
Name Time Method Gut microbiota composition Difference between day 0 and day 21 Illumina sequencing of 16SrDNA
- Secondary Outcome Measures
Name Time Method Fecal short-chain fatty acids Difference between day 0 and day 21 Gas chromatography using Flame ionization detector (GC- FID)
Fecal bile acids Difference between day 0 and day 21 Gas chromatography-mass spectrometry (GC/MS)
Exhaled acetate Difference between day 0 and day 21 Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Fecal conjugated-linoleic acids Difference between day 0 and day 21 Gas chromatography using Flame ionization detector (GC- FID)
Exhaled propionate Difference between day 0 and day 21 Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled H2S Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled CH4 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled H2 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - nausea Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled O2 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled butyrate Difference between day 0 and day 21 Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled C2 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled CO2 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled CO Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - flatulences Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - gastrointestinal reflux Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled N2 Difference between day 0 and day 21 Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Exhaled volatile compounds Difference between day 0 and day 21 Gas chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - discomfort Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - cramps Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - rumbling Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - burps Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Gastro-intestinal symptom - bloating Difference between Day 0 and Day 21 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Trial Locations
- Locations (1)
Center of Investigation in Clinical Nutrition
🇧🇪Louvain-la-Neuve, Belgium