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

NCT03494491 | Completed

• 1 other identifier: FiberTAG1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Exhaled acetate

  Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

• Exhaled propionate

  Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

• Exhaled butyrate

  Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

Secondary Outcomes (21)

• Gut microbiota

  within 4 days before the second test day

• Fecal short-chain fatty acids

  Within 4 days before the ingestion of chitin-glucan

• Fecal conjugated-linoleic acids

  Within 4 days before the ingestion of chitin-glucan

• Fecal bile acids

  Within 4 days before the ingestion of chitin-glucan

• Gastro-intestinal symptom - discomfort

  Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

Interventions

Chitin-glucan DIETARY_SUPPLEMENT

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

Maltodextrin DIETARY_SUPPLEMENT

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

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
• 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

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 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, 1348, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33461385 DERIVED

MeSH Terms

Interventions

carboxymethyl-chitin-glucan; maltodextrin

Study Officials

• Nathalie Delzenne, Prof

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 11, 2018
• Study Start: March 8, 2018
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

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 partener (Consortium agreement)

Locations

BE (1)