Healthy Clinical Trial
Official title:
Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
Verified date | April 2018 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 15 |
Est. completion date | March 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 - 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 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 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Center of Investigation in Clinical Nutrition | Louvain-La-Neuve |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exhaled acetate | 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) | 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 | |
Primary | Exhaled propionate | 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) | 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 | |
Primary | Exhaled butyrate | 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) | 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 | |
Secondary | Gut microbiota | Illumina sequencing of 16SrDNA and GC-FID | within 4 days before the second test day | |
Secondary | Fecal short-chain fatty acids | Gaz chromatography using Flame ionization detector (GC- FID) | Within 4 days before the ingestion of chitin-glucan | |
Secondary | Fecal conjugated-linoleic acids | Gaz chromatography using Flame ionization detector (GC- FID) | Within 4 days before the ingestion of chitin-glucan | |
Secondary | Fecal bile acids | Gas chromatography-mass spectrometry (GC/MS) | Within 4 days before the ingestion of chitin-glucan | |
Secondary | Gastro-intestinal symptom - discomfort | 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) | 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 | |
Secondary | Gastro-intestinal symptom - nausea | 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) | 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 | |
Secondary | Gastro-intestinal symptom - bloating | 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) | 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 | |
Secondary | Gastro-intestinal symptom - flatulences | 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) | 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 | |
Secondary | Gastro-intestinal symptom - gastrointestinal reflux | 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) | 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 | |
Secondary | Gastro-intestinal symptom - cramps | 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) | 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 | |
Secondary | Gastro-intestinal symptom - rumbling | 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) | 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 | |
Secondary | Gastro-intestinal symptom - burps | 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) | 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 | |
Secondary | Exhaled C2 | 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) | 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 | |
Secondary | Exhaled CO2 | 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) | 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 | |
Secondary | Exhaled H2S | 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) | 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 | |
Secondary | Exhaled O2 | 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) | 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 | |
Secondary | Exhaled N2 | 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) | 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 | |
Secondary | Exhaled CH4 | 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) | 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 | |
Secondary | Exhaled CO | 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) | 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 | |
Secondary | Exhaled H2 | 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) | 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 | |
Secondary | Exhaled volatils compounds (for other short-chain fatty acids and other volatile organic compounds) | 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) | 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 |
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