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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Chitin-glucan fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Supplementation during 3 weeks with 4.5g of chitin-glucan
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitin-glucan<br>Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber | Dietary Supplement: Chitin-glucan fiber<br>* 4.5g per day of chitin-glucan during 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota composition | Illumina sequencing of 16SrDNA | Difference between day 0 and day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal short-chain fatty acids | Gas chromatography using Flame ionization detector (GC- FID) | Difference between day 0 and day 21 | 
| Fecal bile acids | Gas chromatography-mass spectrometry (GC/MS) | Difference between day 0 and day 21 | 
| Fecal conjugated-linoleic acids | Gas chromatography using Flame ionization detector (GC- FID) | Difference between day 0 and day 21 | 
| Exhaled acetate | Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled propionate | Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled butyrate | Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled C2 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled CO2 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled H2S | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled O2 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled N2 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled CH4 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled CO | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled H2 | Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Exhaled volatile compounds | Gas chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion) | Difference between day 0 and day 21 | 
| Gastro-intestinal symptom - discomfort | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - nausea | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - bloating | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - flatulences | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - gastrointestinal reflux | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - cramps | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - rumbling | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - burps | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation | 3 weeks | 
| Gastro-intestinal symptom - discomfort | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - nausea | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - bloating | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - flatulences | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - gastrointestinal reflux | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - cramps | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - rumbling | 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) | Difference between Day 0 and Day 21 | 
| Gastro-intestinal symptom - burps | 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) | Difference between Day 0 and Day 21 |