Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects (ROQ_NUTRIMETAB)

Nealth Sarl

Status and phase

Completed

Phase 1

Conditions

Overweight

Treatments

Dietary Supplement: NUTRIOSE FB06

Dietary Supplement: GLUCIIDEX 21

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01897662

ROQ_NUTRIMETAB10

2011-A00062-39 (Registry Identifier)

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." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.

The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.

Enrollment

76 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy people
aged between 20 and 50 years
BMI between 27 and 29 kg/m2
without metabolic syndrome
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, agents acting on satiety)
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 diet during the last 3 months
person in vegetarian or vegan diet
person who donated blood during the 3 months preceding the study
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.