Effect of Nutriose Supplementation on Satiety, Weight Los... | NCT01897662

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

NCT01897662

Sponsor

Nealth Sarl

Status

Completed

Last Update Posted

Jul 12, 2013Estimated

Enrollment

76Actual

Phase

Phase 1

Conditions

Overweight

Interventions

NUTRIOSE FB06
GLUCIIDEX 21

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A00062-39	Registry Identifier	AFSSAPS (France)

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2013

Last Update Posted Date

Jul 12, 2013Estimated

Name	Class
Roquette Freres	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NUTRIOSE	Experimental	Group of volunteers fed with NUTRIOSE	Dietary Supplement: NUTRIOSE FB06
GLUCIDEX	Active Comparator	Group of volunteers fed with GLUCIDEX	Dietary Supplement: GLUCIIDEX 21

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NUTRIOSE FB06	Dietary Supplement	14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day	NUTRIOSE

Measure	Description	Time Frame
body weight		D-7; D28; D56; D84

Measure	Description	Time Frame
satiety		D-7; D28; D56; D84
energy intake		D-7; D28; D56; D84
BMI

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul VALENSI, PU/PH, Chef de service	centre de recherche en nutrition humaine (CRNH)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier		Bondy	Seine-Saint-Denis	93143	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21164548	Background	Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.
19215668	Background

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight