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

Phase 1

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: NUTRIOSE FB06; Dietary Supplement: GLUCIIDEX 21

• Registration Number: NCT01897662
• Lead Sponsor: Nealth Sarl

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." 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-11
• Last Update Submitted: 2013-07-11
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NUTRIOSE	NUTRIOSE FB06	Group of volunteers fed with NUTRIOSE
GLUCIDEX	GLUCIIDEX 21	Group of volunteers fed with GLUCIDEX

Primary Outcome Measures

Name	Time	Method
body weight	D-7; D28; D56; D84

Secondary Outcome Measures

Name	Time	Method
satiety	D-7; D28; D56; D84
energy intake	D-7; D28; D56; D84
BMI	D-7; D28; D56; D84	Body Mass Index
body fat	D-7; D28; D56; D84	measured by DEXA
waist size	D-7; D28; D56; D84
glycemia	D-7; D28; D56; D84
insulinemia	D-7; D28; D56; D84
total cholesterol	D-7; D28; D56; D84
LDL cholesterol	D-7; D28; D56; D84
HDL cholesterol	D-7; D28; D56; D84
triglyceridemia	D-7; D28; D56; D84
HOMA	D-7; D28; D56; D84	homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion)
microbiota	D-7; D28; D56; D84	measured by RT-PCR
blood pressure	D-7; D28; D56; D84
digestive tolerance	D-7; D28; D56; D84	measured with daily questionnaires

Trial Locations

Locations (1)

CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier; 🇫🇷 Bondy, Seine-Saint-Denis, France