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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiometabolic Risk, Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitin-Glucan supplementation<br> | Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger)<br>* The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.<br>|
| Placebo Comparator: Placebo supplementation<br> | Dietary Supplement: Placebo<br>* The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal SCFA | Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector | baseline and three weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers