Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTChitin-glucan fiber
4.5g per day of chitin-glucan during 3 weeks
Sponsors
Nathalie Delzenne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Supplementation during 3 weeks with 4.5g of chitin-glucan
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | Difference between day 0 and day 21 | Illumina sequencing of 16SrDNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal bile acids | Difference between day 0 and day 21 | Gas chromatography-mass spectrometry (GC/MS) |
| Fecal conjugated-linoleic acids | Difference between day 0 and day 21 | Gas chromatography using Flame ionization detector (GC- FID) |
| 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) |
| 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 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 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 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 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 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) |
| Fecal short-chain fatty acids | Difference between day 0 and day 21 | Gas chromatography using Flame ionization detector (GC- FID) |
| 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) |
| 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 | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - nausea | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - bloating | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - flatulences | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - gastrointestinal reflux | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - cramps | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - rumbling | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| Gastro-intestinal symptom - burps | 3 weeks | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation |
| 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) |
Countries
Belgium
Outcome results
None listed