Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation

The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Chitin-glucan fiber

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 1348
    • Center of Investigation in Clinical Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• H2 - producer
• 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 antibiotic, probiotic, prebiotic, fiber supplement, and/or any product 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 two weeks before the screening test visit
• Subjects presenting an allergy or intolerance to one component of the product tested

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chitin-glucan; Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber	Dietary supplement: Chitin-glucan fiber; 4.5g per day of chitin-glucan during 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota composition	Illumina sequencing of 16SrDNA	Difference between day 0 and day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal short-chain fatty acids	Gas chromatography using Flame ionization detector (GC- FID)	Difference between day 0 and day 21
Fecal bile acids	Gas chromatography-mass spectrometry (GC/MS)	Difference between day 0 and day 21
Fecal conjugated-linoleic acids	Gas chromatography using Flame ionization detector (GC- FID)	Difference between day 0 and day 21
Exhaled acetate	Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled propionate	Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled butyrate	Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled C2	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled CO2	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled H2S	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled O2	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled N2	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled CH4	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled CO	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled H2	Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Exhaled volatile compounds	Gas chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between day 0 and day 21
Gastro-intestinal symptom - discomfort	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - nausea	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - bloating	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - flatulences	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - gastrointestinal reflux	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - cramps	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - rumbling	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - burps	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation	3 weeks
Gastro-intestinal symptom - discomfort	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - nausea	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - bloating	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - flatulences	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - gastrointestinal reflux	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - cramps	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - rumbling	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21
Gastro-intestinal symptom - burps	100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)	Difference between Day 0 and Day 21

Collaborators and Investigators

• Sponsor: Nathalie Delzenne

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2018
• Primary Completion (ACTUAL): May 18, 2018
• Study Completion (ACTUAL): May 18, 2018

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (ACTUAL): April 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FiberTAG2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All data will be shared by the partners from the Consortium agreement.

• exhaled volatile metabolites
• gut microbiota derived metabolites
• visual analog scale data
• concomitant medication, inclusion/exclusion criteria, adverse event, food and beverage consumption Data will be shared at the end of the study.

• IPD Sharing Time Frame: At the end of the study
• IPD Sharing Access Criteria: Belonging to the project Consortium
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No