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

NCT01897662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2013-07-12

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

NUTRIOSE FB06

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

DIETARY_SUPPLEMENT

GLUCIIDEX 21

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

Sponsors & Collaborators

  • Roquette Freres

    collaborator INDUSTRY

  • Nealth Sarl

    lead NETWORK

Principal Investigators

  • Paul VALENSI, PU/PH, Chef de service · centre de recherche en nutrition humaine (CRNH)

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897662 on ClinicalTrials.gov