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

NCT03505177 | Completed

• 1 other identifier: FiberTAG2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Gut microbiota composition

  Illumina sequencing of 16SrDNA

  Difference between day 0 and day 21

Secondary Outcomes (31)

• Fecal short-chain fatty acids

  Difference between day 0 and day 21

• Fecal bile acids

  Difference between day 0 and day 21

• Fecal conjugated-linoleic acids

  Difference between day 0 and day 21

• Exhaled acetate

  Difference between day 0 and day 21

• Exhaled propionate

  Difference between day 0 and day 21

Study Arms (1)

Chitin-glucan

EXPERIMENTAL

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

Dietary Supplement: Chitin-glucan fiber

Interventions

Chitin-glucan fiber DIETARY_SUPPLEMENT

4.5g per day of chitin-glucan during 3 weeks

Chitin-glucan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathalie Delzenne: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, 1348, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Supplementation during 3 weeks with 4.5g of chitin-glucan

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 23, 2018
• Study Start: April 22, 2018
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study
• Access Criteria: Belonging to the project Consortium

Locations

BE (1)