CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 76 enrolled
Drug / intervention
NUTRIOSE FB06 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01897662
NCT01897662Phase 1Completed

Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects

Nealth Sarl·interventional·Posted Jul 12, 2013·Updated Jul 12, 2013

In Brief

A Phase 1 clinical trial evaluating NUTRIOSE FB06 and GLUCIIDEX 21 for Overweight. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight
CountriesFrance
CollaboratorsRoquette Freres

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.0 years ago

Interventions

NUTRIOSE FB06dietary

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

GLUCIIDEX 21dietary

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