FITACHITIN: 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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03773900
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiometabolic Risk; Abdominal Obesity	Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger); Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• 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: Nov 7, 2018
• Actual Primary Completion Date: Jun 6, 2019
• Actual Study Completion Date: Jun 6, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Fecal SCFA [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 [baseline and three weeks]

   Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing

2. fecal biliary acids [baseline and three weeks]

   Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)

3. fecal PolyUnsaturated Fatty Acids (PUFA) [baseline and three weeks]

   Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)

4. fecal albumin [baseline and three weeks]

   Change from baseline fecal albumin by immunoenzymatic technique (ELISA)

5. fecal zonulin [baseline and three weeks]

   Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)

6. fecal calprotectin [baseline and three weeks]

   Change from baseline fecal calprotectin by Phadia 100 system

7. TLR-agonist in stool [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 [baseline and three weeks]

   by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch

9. body composition [baseline and three weeks]

   Change from baseline bodycompositio by bioimpedancemetry

10. Change from plasma glucose kinetics [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 [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 [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 [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 [baseline and three weeks]

    Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method

15. resting energy expenditure [baseline and three weeks]

    Change from baseline resting energy expenditure by indirect calorimetry

16. stool consistency [every week, up to three weeks]

    by Bristol Stool Chart (type1-7)

17. stool frequency [every week, up to three weeks]

    by questionnaire

18. gastro-intestinal symptoms [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 [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 [baseline and three weeks]

    by three day food record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud	Pierre-Bénite		France	69310

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03773900
• Other Study ID Numbers: 69HCL18_0362
• First Posted: Dec 12, 2018
• Last Update Posted: Aug 13, 2019
• Last Verified: Aug 1, 2019

• 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: Obesity, Abdominal

Study Results

No Results Posted as of Aug 13, 2019