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

Université Catholique de Louvain15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Chitin-glucanDIETARY_SUPPLEMENT

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

MaltodextrinDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, Belgium

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Gut microbiota

Illumina sequencing of 16SrDNA and GC-FID

Time frame: within 4 days before the second test day

Fecal short-chain fatty acids

Gaz chromatography using Flame ionization detector (GC- FID)

Time frame: Within 4 days before the ingestion of chitin-glucan

Fecal conjugated-linoleic acids

Data from ClinicalTrials.gov

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Gaz chromatography using Flame ionization detector (GC- FID)

Time frame: Within 4 days before the ingestion of chitin-glucan

Fecal bile acids

Gas chromatography-mass spectrometry (GC/MS)

Time frame: Within 4 days before the ingestion of chitin-glucan

Gastro-intestinal symptom - discomfort

100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - 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)

Time frame: 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

Gastro-intestinal symptom - nausea

Time frame: 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

Gastro-intestinal symptom - bloating

Time frame: 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

Gastro-intestinal symptom - flatulences

Time frame: 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

Gastro-intestinal symptom - gastrointestinal reflux

Time frame: 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

Gastro-intestinal symptom - cramps

Time frame: 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

Gastro-intestinal symptom - rumbling

Time frame: 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

Gastro-intestinal symptom - burps

Time frame: 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

Exhaled C2

Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - 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)

Time frame: 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 CO2

Time frame: 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 H2S

Time frame: 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 O2

Time frame: 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 N2

Time frame: 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 CH4

Time frame: 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 CO

Time frame: 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 H2

Time frame: 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 volatils compounds (for other short-chain fatty acids and other volatile organic compounds)

Gaz chromatography using selected ion flow tube mass spectrometry - 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)

Time frame: 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