Abdominal Obesity, Cardiometabolic Risk
Conditions
Keywords
chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers
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.
Interventions
DIETARY_SUPPLEMENTKiotransine (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.
DIETARY_SUPPLEMENTPlacebo
The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal SCFA | baseline and three weeks | Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fecal biliary acids | baseline and three weeks | Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography) |
| fecal PolyUnsaturated Fatty Acids (PUFA) | baseline and three weeks | Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography) |
| fecal albumin | baseline and three weeks | Change from baseline fecal albumin by immunoenzymatic technique (ELISA) |
| fecal zonulin | baseline and three weeks | Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA) |
| fecal calprotectin | baseline and three weeks | Change from baseline fecal calprotectin by Phadia 100 system |
| TLR-agonist in stool | baseline and three weeks | Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules |
| 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 |
| body composition | baseline and three weeks | Change from baseline bodycompositio by bioimpedancemetry |
| 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 |
| gut microbiota composition | baseline and three weeks | Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing |
| 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 |
| 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 |
| Cholesterol Total, Cholesterol LDL | baseline and three weeks | Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method |
| resting energy expenditure | baseline and three weeks | Change from baseline resting energy expenditure by indirect calorimetry |
| stool consistency | every week, up to three weeks | by Bristol Stool Chart (type1-7) |
| stool frequency | every week, up to three weeks | by questionnaire |
| 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)) |
| quality of life during the study | baseline and three weeks | change from baseline quality of life during the study by SF 36 questionnaire |
| change from baseline dietary intake of fibre | baseline and three weeks | by three day food record |
| 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 |
Countries
France
Outcome results
None listed