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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NUTRIOSE

Group of volunteers fed with NUTRIOSE

Group Type EXPERIMENTAL

NUTRIOSE FB06

Intervention Type DIETARY_SUPPLEMENT

14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day

GLUCIDEX

Group of volunteers fed with GLUCIDEX

Group Type ACTIVE_COMPARATOR

GLUCIIDEX 21

Intervention Type DIETARY_SUPPLEMENT

7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day

Interventions

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NUTRIOSE FB06

14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day

Intervention Type DIETARY_SUPPLEMENT

GLUCIIDEX 21

7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes