Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers

Not Applicable

Completed

• Conditions: Cardiometabolic Risk; Abdominal Obesity
• Interventions: Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger); Dietary Supplement: Placebo

• Registration Number: NCT03773900
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Healthy
• Non-smokers
• Body mass index between 25 and 35 kg/m2
• Waist circumference < 80cm for women and > 94 cm for men
• Fiber intake <25g/day

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Exclusion Criteria

• Medical history of digestive surgery or disease
• Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
• Current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit
• Feeding particular diet such as vegetarian diet or hyperprotein diet
• Current weight loss diet
• Pregnant or lactating woman or woman who did not use effective contraception
• Drinking more than 3 glasses of alcohol per day (>30g/day)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chitin-Glucan supplementation	Kiotransine (chitin-glucan from aspergillus niger)	-
Placebo supplementation	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fecal SCFA	baseline and three weeks	Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector

Secondary Outcome Measures

Name	Time	Method
gut microbiota composition	baseline and three weeks	Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing
fecal biliary acids	baseline and three weeks	Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)
fecal PolyUnsaturated Fatty Acids (PUFA)	baseline and three weeks	Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)
fecal albumin	baseline and three weeks	Change from baseline fecal albumin by immunoenzymatic technique (ELISA)
fecal zonulin	baseline and three weeks	Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)
fecal calprotectin	baseline and three weeks	Change from baseline fecal calprotectin by Phadia 100 system
TLR-agonist in stool	baseline and three weeks	Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules
Change from baseline CO2, CH4 and H2 kinetics in exhaled gases	baseline and three weeks	by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch
body composition	baseline and three weeks	Change from baseline bodycompositio by bioimpedancemetry
Change from plasma glucose kinetics	baseline and three weeks	by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Change from plasma insulin kinetics	baseline and three weeks	by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics	baseline and three weeks	by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
plasma TriacylGlycerol (TG) kinetics	baseline and three weeks	Change from plasma TriacylGlycerol (TG) kinetics by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Cholesterol Total, Cholesterol LDL	baseline and three weeks	Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method
resting energy expenditure	baseline and three weeks	Change from baseline resting energy expenditure by indirect calorimetry
stool consistency	every week, up to three weeks	by Bristol Stool Chart (type1-7)
stool frequency	every week, up to three weeks	by questionnaire
change from baseline dietary intake of fibre	baseline and three weeks	by three day food record
gastro-intestinal symptoms	every week, up to three weeks	by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum))
quality of life during the study	baseline and three weeks	change from baseline quality of life during the study by SF 36 questionnaire

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France