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

Abdominal Obesity Clinical Trial

— FITACHITIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773900
• Other study ID #: 69HCL18_0362
• Status: Completed
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: June 6, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Obesity
• Cardiometabolic Risk
• Obesity, Abdominal

Intervention

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
The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal SCFA	Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector	baseline and three weeks
Secondary	gut microbiota composition	Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing	baseline and three weeks
Secondary	fecal biliary acids	Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)	baseline and three weeks
Secondary	fecal PolyUnsaturated Fatty Acids (PUFA)	Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)	baseline and three weeks
Secondary	fecal albumin	Change from baseline fecal albumin by immunoenzymatic technique (ELISA)	baseline and three weeks
Secondary	fecal zonulin	Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)	baseline and three weeks
Secondary	fecal calprotectin	Change from baseline fecal calprotectin by Phadia 100 system	baseline and three weeks
Secondary	TLR-agonist in stool	Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules	baseline and three weeks
Secondary	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
Secondary	body composition	Change from baseline bodycompositio by bioimpedancemetry	baseline and three weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cholesterol Total, Cholesterol LDL	Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method	baseline and three weeks
Secondary	resting energy expenditure	Change from baseline resting energy expenditure by indirect calorimetry	baseline and three weeks
Secondary	stool consistency	by Bristol Stool Chart (type1-7)	every week, up to three weeks
Secondary	stool frequency	by questionnaire	every week, up to three weeks
Secondary	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
Secondary	quality of life during the study	change from baseline quality of life during the study by SF 36 questionnaire	baseline and three weeks
Secondary	change from baseline dietary intake of fibre	by three day food record	baseline and three weeks

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