Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.

Study Overview
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Brief Summary
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NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a soluble dietary fiber. The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.

Official Title
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Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.

Conditions
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Microbiota, Dietary Fibers

Intervention / Treatment
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* Dietary Supplement: NUTRIOSE FB06
* Dietary Supplement: GLUCIDEX 21


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 to 50 years, BMI 18 to 25 kg/m2, absence of known or scalable organic or psychiatric disease no history of chronic gastrointestinal disease having a bowel regularity (1-3 defecation per day, of normal consistency), person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women) having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine) no pregnant nor nursing women covered by Social Security negative serology for hepatitis B/C and HIV who signed the informed consent form Exclusion Criteria: persons abusing drugs (laxatives, anti-diarrheal) person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study person intolerant to gluten and / or allergic to wheat flour person in vegetarian or vegan diet Inclusion in another clinical study subjects receiving over 4,500 Euros in the last 12 months (including the present study) subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUTRIOSE<br>group of volunteers fed with NUTRIOSE | Dietary Supplement: NUTRIOSE FB06<br>* 15g/day NUTRIOSE FB06<br>|
| Active Comparator: GLUCIDEX<br>gruop of volunteers fed with GLUCIDEX | Dietary Supplement: GLUCIDEX 21<br>* 15g/day GLUCIDEX 21<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clostridium Perfringens rate in stool |  | D0 ; D14 ; D28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| digestive tolerance |  | J0 to J28 (every day) | 
| stool pH |  | D0 ; D14; D28 | 
| total stool flora |  | D0 ; D14 ; D28 | 
| Bacteroides rate in stool |  | D0 ; D14 ; D28 | 
| Eubacterium rectal rate in stool |  | D0 ; D14 ; D28 | 
| Clostridium coccoides rate in stool |  | D0 ; D14 ; D28 | 
| Clostridium leptum rate in stool |  | D0 ; D14 ; D28 | 
| Bifidobacteria rate in stool |  | D0 ; D14 ; D28 | 
| Lactobacteria rate in stool |  | D0 ; D14 ; D28 | 
| Streptococcus rate in stool |  | D0 ; D14 ; D28 | 
| Enterococcus rate in stool |  | D0 ; D14 ; D28 | 
| Bacteroidetes rate in stool |  | D0 ; D14 ; D28 | 
| Actinobacteria rate in stool |  | D0 ; D14; D28 | 
| Firmicutes rate in stool |  | D0 ; D14 ; D28 | 
| E. Coli rate in stool |  | D0 ; D14 ; D28 | 
| Clostridium difficile rate in stool |  | D0 ; D14 ; D28 | 
| Faecalibacterium prausnitzii rate in stool |  | D0 ; D14 ; D28 | 
| Clostridium difficile typa A and B rate in stool |  | D0 ; D14 ; D28 | 
| E. Coli EIEC + EPEC (eae gene) rate in stool |  | D0 ; D14 ; D28 | 
| Shigella + E. Coli EIEC (ipaH gene) rate in stool |  | D0 ; D14 ; D28 | 
| Listeria Monocytogenes rate in stool |  | D0 ; D14 ; D28 | 
| Yersinia Enterocolitica rate in stool |  | D0 ; D14 ; D28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional food, digestive tolerance, microbiota, bifidogenic effect