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Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration

U

Université Catholique de Louvain

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Maltodextrin
Dietary Supplement: Chitin-glucan

Study type

Interventional

Funder types

Other

Identifiers

NCT03494491
FiberTAG1

Details and patient eligibility

About

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).

Enrollment

15 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
  • 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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