Clinical trial NCT03494491: Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
Official title: Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Exhaled acetate
timeFrame: 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
measure: Exhaled propionate
timeFrame: 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
measure: Exhaled butyrate
timeFrame: 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:
measure: Gut microbiota
timeFrame: within 4 days before the second test day
measure: Fecal short-chain fatty acids
timeFrame: Within 4 days before the ingestion of chitin-glucan
measure: Fecal conjugated-linoleic acids
timeFrame: Within 4 days before the ingestion of chitin-glucan
measure: Fecal bile acids
timeFrame: Within 4 days before the ingestion of chitin-glucan
measure: Gastro-intestinal symptom - discomfort
timeFrame: 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
measure: Gastro-intestinal symptom - nausea
timeFrame: 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
measure: Gastro-intestinal symptom - bloating
timeFrame: 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
measure: Gastro-intestinal symptom - flatulences
timeFrame: 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
measure: Gastro-intestinal symptom - gastrointestinal reflux
timeFrame: 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
measure: Gastro-intestinal symptom - cramps
timeFrame: 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
measure: Gastro-intestinal symptom - rumbling
timeFrame: 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
measure: Gastro-intestinal symptom - burps
timeFrame: 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
measure: Exhaled C2
timeFrame: 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
measure: Exhaled CO2
timeFrame: 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
measure: Exhaled H2S
timeFrame: 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
measure: Exhaled O2
timeFrame: 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
measure: Exhaled N2
timeFrame: 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
measure: Exhaled CH4
timeFrame: 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
measure: Exhaled CO
timeFrame: 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
measure: Exhaled H2
timeFrame: 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
measure: Exhaled volatils compounds (for other short-chain fatty acids and other volatile organic compounds)
timeFrame: 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
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition
Study officials:
affiliation: UCL
name: Nathalie Delzenne, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.