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

NCT ID: NCT03505177

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-22
• Study Completion Date: 2018-05-18

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Chitin-glucan

Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber

Group Type: EXPERIMENTAL

Chitin-glucan fiber

Intervention Type: DIETARY_SUPPLEMENT

4.5g per day of chitin-glucan during 3 weeks

Interventions

Chitin-glucan fiber

4.5g per day of chitin-glucan during 3 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nathalie Delzenne

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Delzenne

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

FiberTAG2

Identifier Type: -

Identifier Source: org_study_id