Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Abdominal Obesity
Keywords: chitin-glucan
gut microbiota
Fecal Short Chain Fatty Acid (SCFA)
cardiometabolic risk
nutritional challenge test
biomarkers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Fecal SCFA
timeFrame: baseline and three weeks
Secondary outcomes:
measure: gut microbiota composition
timeFrame: baseline and three weeks
measure: fecal biliary acids
timeFrame: baseline and three weeks
measure: fecal PolyUnsaturated Fatty Acids (PUFA)
timeFrame: baseline and three weeks
measure: fecal albumin
timeFrame: baseline and three weeks
measure: fecal zonulin
timeFrame: baseline and three weeks
measure: fecal calprotectin
timeFrame: baseline and three weeks
measure: TLR-agonist in stool
timeFrame: baseline and three weeks
measure: Change from baseline CO2, CH4 and H2 kinetics in exhaled gases
timeFrame: baseline and three weeks
measure: body composition
timeFrame: baseline and three weeks
measure: Change from plasma glucose kinetics
timeFrame: baseline and three weeks
measure: Change from plasma insulin kinetics
timeFrame: baseline and three weeks
measure: Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics
timeFrame: baseline and three weeks
measure: plasma TriacylGlycerol (TG) kinetics
timeFrame: baseline and three weeks
measure: Cholesterol Total, Cholesterol LDL
timeFrame: baseline and three weeks
measure: resting energy expenditure
timeFrame: baseline and three weeks
measure: stool consistency
timeFrame: every week, up to three weeks
measure: stool frequency
timeFrame: every week, up to three weeks
measure: gastro-intestinal symptoms
timeFrame: every week, up to three weeks
measure: quality of life during the study
timeFrame: baseline and three weeks
measure: change from baseline dietary intake of fibre
timeFrame: baseline and three weeks
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud
Study officials:
References: