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

Nealth Sarl

Status and phase

Completed

Phase 1

Conditions

Dietary Fibers

Microbiota

Treatments

Dietary Supplement: NUTRIOSE FB06

Dietary Supplement: GLUCIDEX 21

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01897649

ROQ_NUTRIFLORE10

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.