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 (FITACHITIN)

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.

Study Overview

• Status: Completed
• Conditions: Cardiometabolic Risk; Abdominal Obesity
• Intervention / Treatment: Dietary supplement: Kiotransine (chitin-glucan from aspergillus niger); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: biomarkers; gut microbiota; cardiometabolic risk; nutritional challenge test; chitin-glucan; Fecal Short Chain Fatty Acid (SCFA)
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: 69HCL18_0362

Drug and device information, study documents

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