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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505177
• Other study ID #: FiberTAG2
• Status: Completed
• Phase: N/A
• Start date: April 22, 2018
• Est. completion date: May 18, 2018

Study information

• Verified date: May 2018
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 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

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Chitin-glucan fiber
4.5g per day of chitin-glucan during 3 weeks

Locations

Country	Name	City	State
Belgium	Center of Investigation in Clinical Nutrition	Louvain-la-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Nathalie Delzenne

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota composition	Illumina sequencing of 16SrDNA	Difference between day 0 and day 21
Secondary	Fecal short-chain fatty acids	Gas chromatography using Flame ionization detector (GC- FID)	Difference between day 0 and day 21
Secondary	Fecal bile acids	Gas chromatography-mass spectrometry (GC/MS)	Difference between day 0 and day 21
Secondary	Fecal conjugated-linoleic acids	Gas chromatography using Flame ionization detector (GC- FID)	Difference between day 0 and day 21
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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