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

NCT ID: NCT03494491

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-08
• Study Completion Date: 2018-03-30

Brief Summary

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).

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Interventions

Chitin-glucan

Second test day (D2), subjects will received 4.5g of chitine-glucan

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

First test day (D0), subjects will received 4.5g of maltodextrin.

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
• 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

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

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Delzenne

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie Delzenne, Prof

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, , Belgium

Countries

Belgium

References

Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Mailleux F, Vercammen J, Bindels LB, Cani PD, Nazare JA, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Noninvasive monitoring of fibre fermentation in healthy volunteers by analyzing breath volatile metabolites: lessons from the FiberTAG intervention study. Gut Microbes. 2021 Jan-Dec;13(1):1-16. doi: 10.1080/19490976.2020.1862028.

Reference Type: DERIVED

PMID: 33461385 (View on PubMed)

Other Identifiers

FiberTAG1

Identifier Type: -

Identifier Source: org_study_id