Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
- Conditions
- Healthy
- Registration Number
- NCT03494491
- Lead Sponsor
- Université Catholique de Louvain
- Brief Summary
The aim of this research study is to characterize the fermentation of chitin-glucan fiber by assessing the volatile compounds released in the breath. For this purpose, an interventional study with control will be performed. After a single administration of 4.5 g of chitin-glucan fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,...) will be measured during twelve hours. These results will be compared to the exhaled volatile compounds measured during twelve hours after supplementation with 4.5g of maltodextrin (placebo).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- For women: use of highly effective contraception
- H2 - producer as evidenced by the screening test (described in latter section)
- 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 antibiotics, probiotics, prebiotics, fiber supplement, and/or any products 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 1 month 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
- CROSSOVER
- Primary Outcome Measures
Name Time Method Exhaled acetate Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled propionate Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled butyrate Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
- Secondary Outcome Measures
Name Time Method Fecal short-chain fatty acids Within 4 days before the ingestion of chitin-glucan Gaz chromatography using Flame ionization detector (GC- FID)
Fecal bile acids Within 4 days before the ingestion of chitin-glucan Gas chromatography-mass spectrometry (GC/MS)
Gastro-intestinal symptom - bloating Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gut microbiota within 4 days before the second test day Illumina sequencing of 16SrDNA and GC-FID
Gastro-intestinal symptom - discomfort Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled CO Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gastro-intestinal symptom - gastrointestinal reflux Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled C2 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Fecal conjugated-linoleic acids Within 4 days before the ingestion of chitin-glucan Gaz chromatography using Flame ionization detector (GC- FID)
Gastro-intestinal symptom - rumbling Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled H2S Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled O2 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled H2 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled volatils compounds (for other short-chain fatty acids and other volatile organic compounds) Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gastro-intestinal symptom - nausea Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gastro-intestinal symptom - flatulences Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gastro-intestinal symptom - cramps Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled CH4 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Gastro-intestinal symptom - burps Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled CO2 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled N2 Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Trial Locations
- Locations (1)
Center of Investigation in Clinical Nutrition
🇧🇪Louvain-La-Neuve, Belgium