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Completed

NCT Number: NCT03773900

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

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.

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Key information

Conditions

Cardiometabolic Risk Abdominal Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kiotransine (chitin-glucan from aspergillus niger)

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Fecal SCFA

    Time frame: baseline and three weeks

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FITACHITIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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