Dietary Fibers, Microbiota
Conditions
Keywords
functional food, digestive tolerance, microbiota, bifidogenic effect
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNUTRIOSE FB06
15g/day NUTRIOSE FB06
DIETARY_SUPPLEMENTGLUCIDEX 21
15g/day GLUCIDEX 21
Sponsors
Roquette Freres
Nealth Sarl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clostridium Perfringens rate in stool | D0 ; D14 ; D28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| digestive tolerance | J0 to J28 (every day) |
| 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 |
| Bacteroidetes rate in stool | D0 ; D14 ; D28 |
Countries
France
Outcome results
None listed