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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 (FITACHITIN)

Primary Purpose

Cardiometabolic Risk, Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kiotransine (chitin-glucan from aspergillus niger)
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiometabolic Risk focused on measuring chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chitin-Glucan supplementation

Placebo supplementation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

gut microbiota composition
Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing
fecal biliary acids
Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)
fecal PolyUnsaturated Fatty Acids (PUFA)
Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)
fecal albumin
Change from baseline fecal albumin by immunoenzymatic technique (ELISA)
fecal zonulin
Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)
fecal calprotectin
Change from baseline fecal calprotectin by Phadia 100 system
TLR-agonist in stool
Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules
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
body composition
Change from baseline bodycompositio by bioimpedancemetry
Change from plasma glucose kinetics
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Change from plasma insulin kinetics
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
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
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
Cholesterol Total, Cholesterol LDL
Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method
resting energy expenditure
Change from baseline resting energy expenditure by indirect calorimetry
stool consistency
by Bristol Stool Chart (type1-7)
stool frequency
by questionnaire
gastro-intestinal symptoms
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
change from baseline quality of life during the study by SF 36 questionnaire
change from baseline dietary intake of fibre
by three day food record

Full Information

First Posted
November 16, 2018
Last Updated
August 12, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03773900
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Risk, Abdominal Obesity
Keywords
chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chitin-Glucan supplementation
Arm Type
Experimental
Arm Title
Placebo supplementation
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Kiotransine (chitin-glucan from aspergillus niger)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
Primary Outcome Measure Information:
Title
Fecal SCFA
Description
Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector
Time Frame
baseline and three weeks
Secondary Outcome Measure Information:
Title
gut microbiota composition
Description
Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing
Time Frame
baseline and three weeks
Title
fecal biliary acids
Description
Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)
Time Frame
baseline and three weeks
Title
fecal PolyUnsaturated Fatty Acids (PUFA)
Description
Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)
Time Frame
baseline and three weeks
Title
fecal albumin
Description
Change from baseline fecal albumin by immunoenzymatic technique (ELISA)
Time Frame
baseline and three weeks
Title
fecal zonulin
Description
Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)
Time Frame
baseline and three weeks
Title
fecal calprotectin
Description
Change from baseline fecal calprotectin by Phadia 100 system
Time Frame
baseline and three weeks
Title
TLR-agonist in stool
Description
Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules
Time Frame
baseline and three weeks
Title
Change from baseline CO2, CH4 and H2 kinetics in exhaled gases
Description
by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch
Time Frame
baseline and three weeks
Title
body composition
Description
Change from baseline bodycompositio by bioimpedancemetry
Time Frame
baseline and three weeks
Title
Change from plasma glucose kinetics
Description
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Time Frame
baseline and three weeks
Title
Change from plasma insulin kinetics
Description
by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Time Frame
baseline and three weeks
Title
Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics
Description
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Time Frame
baseline and three weeks
Title
plasma TriacylGlycerol (TG) kinetics
Description
Change from plasma TriacylGlycerol (TG) kinetics by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Time Frame
baseline and three weeks
Title
Cholesterol Total, Cholesterol LDL
Description
Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method
Time Frame
baseline and three weeks
Title
resting energy expenditure
Description
Change from baseline resting energy expenditure by indirect calorimetry
Time Frame
baseline and three weeks
Title
stool consistency
Description
by Bristol Stool Chart (type1-7)
Time Frame
every week, up to three weeks
Title
stool frequency
Description
by questionnaire
Time Frame
every week, up to three weeks
Title
gastro-intestinal symptoms
Description
by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum))
Time Frame
every week, up to three weeks
Title
quality of life during the study
Description
change from baseline quality of life during the study by SF 36 questionnaire
Time Frame
baseline and three weeks
Title
change from baseline dietary intake of fibre
Description
by three day food record
Time Frame
baseline and three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.crnh-rhone-alpes.fr
Description
Related Info

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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

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