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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773900
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiometabolic Risk Abdominal Obesity Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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.




Primary Outcome Measures :
  1. Fecal SCFA [ Time Frame: baseline and three weeks ]
    Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector


Secondary Outcome Measures :
  1. gut microbiota composition [ Time Frame: baseline and three weeks ]
    Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing

  2. fecal biliary acids [ Time Frame: baseline and three weeks ]
    Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)

  3. fecal PolyUnsaturated Fatty Acids (PUFA) [ Time Frame: baseline and three weeks ]
    Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)

  4. fecal albumin [ Time Frame: baseline and three weeks ]
    Change from baseline fecal albumin by immunoenzymatic technique (ELISA)

  5. fecal zonulin [ Time Frame: baseline and three weeks ]
    Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)

  6. fecal calprotectin [ Time Frame: baseline and three weeks ]
    Change from baseline fecal calprotectin by Phadia 100 system

  7. TLR-agonist in stool [ Time Frame: baseline and three weeks ]
    Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules

  8. Change from baseline CO2, CH4 and H2 kinetics in exhaled gases [ Time Frame: baseline and three weeks ]
    by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch

  9. body composition [ Time Frame: baseline and three weeks ]
    Change from baseline bodycompositio by bioimpedancemetry

  10. Change from plasma glucose kinetics [ Time Frame: baseline and three weeks ]
    by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch

  11. Change from plasma insulin kinetics [ Time Frame: baseline and three weeks ]
    by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch

  12. Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics [ Time Frame: baseline and three weeks ]
    by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch

  13. plasma TriacylGlycerol (TG) kinetics [ Time Frame: 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

  14. Cholesterol Total, Cholesterol LDL [ Time Frame: baseline and three weeks ]
    Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method

  15. resting energy expenditure [ Time Frame: baseline and three weeks ]
    Change from baseline resting energy expenditure by indirect calorimetry

  16. stool consistency [ Time Frame: every week, up to three weeks ]
    by Bristol Stool Chart (type1-7)

  17. stool frequency [ Time Frame: every week, up to three weeks ]
    by questionnaire

  18. gastro-intestinal symptoms [ Time Frame: 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))

  19. quality of life during the study [ Time Frame: baseline and three weeks ]
    change from baseline quality of life during the study by SF 36 questionnaire

  20. change from baseline dietary intake of fibre [ Time Frame: baseline and three weeks ]
    by three day food record



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773900


Locations
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France
Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03773900    
Other Study ID Numbers: 69HCL18_0362
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
chitin-glucan
gut microbiota
Fecal Short Chain Fatty Acid (SCFA)
cardiometabolic risk
nutritional challenge test
biomarkers
Additional relevant MeSH terms:
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Obesity, Abdominal
Obesity
Overnutrition
Nutrition Disorders