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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)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Abdominal Obesity
Cardiometabolic Risk

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger)

Study type

Interventional

Funder types

Other

Identifiers

NCT03773900
69HCL18_0362

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

19 participants in 2 patient groups, including a placebo group

Chitin-Glucan supplementation
Experimental group
Treatment:
Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger)
Placebo supplementation
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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