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

Not Applicable

Completed

• Conditions: Healthy

• 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

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study Start: 2018-04-22
• Study First Posted: 2018-04-23
• Status Verified: 2018-05
• Primary Completion: 2018-05-18
• Study Completion: 2018-05-18
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 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 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 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