Status:
COMPLETED
Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.
Lead Sponsor:
Nealth Sarl
Collaborating Sponsors:
Roquette Freres
Conditions:
Microbiota
Dietary Fibers
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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 solu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01897649
Start Date
June 1 2012
End Date
August 1 2012
Last Update
July 12 2013
Active Locations (1)
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1
Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie
Bobigny, France, 93009