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

N

Nathalie Delzenne

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Chitin-glucan fiber

Study type

Interventional

Funder types

Other

Identifiers

NCT03505177
FiberTAG2

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Chitin-glucan
Experimental group
Description:
Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber
Treatment:
Dietary Supplement: Chitin-glucan fiber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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