NCT01897662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

July 9, 2013

Last Update Submit

July 11, 2013

Conditions

Overweight

Keywords

overweightsatietyfunctional foodfood intakedigestive tolerance

Outcome Measures

Primary Outcomes (1)

  • body weight

    D-7; D28; D56; D84

Secondary Outcomes (15)

  • satiety

    D-7; D28; D56; D84

  • energy intake

    D-7; D28; D56; D84

  • BMI

    D-7; D28; D56; D84

  • body fat

    D-7; D28; D56; D84

  • waist size

    D-7; D28; D56; D84

  • +10 more secondary outcomes

Study Arms (2)

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

NUTRIOSE FB06DIETARY_SUPPLEMENT

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

NUTRIOSE
GLUCIIDEX 21DIETARY_SUPPLEMENT

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

GLUCIDEX

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier

Bondy, Seine-Saint-Denis, 93143, France

Location

Related Publications (6)

  • 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.

    PMID: 21164548BACKGROUND

  • Slavin JL, Savarino V, Paredes-Diaz A, Fotopoulos G. A review of the role of soluble fiber in health with specific reference to wheat dextrin. J Int Med Res. 2009 Jan-Feb;37(1):1-17. doi: 10.1177/147323000903700101.

    PMID: 19215668BACKGROUND

  • Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE(R) dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

    PMID: 21591985BACKGROUND

  • Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24. doi: 10.1128/AEM.71.5.2318-2324.2005.

    PMID: 15870317BACKGROUND

  • Suzuki K, Simpson KA, Minnion JS, Shillito JC, Bloom SR. The role of gut hormones and the hypothalamus in appetite regulation. Endocr J. 2010;57(5):359-72. doi: 10.1507/endocrj.k10e-077. Epub 2010 Apr 14.

    PMID: 20424341BACKGROUND

  • Ruskone-Fourmestraux A, Attar A, Chassard D, Coffin B, Bornet F, Bouhnik Y. A digestive tolerance study of maltitol after occasional and regular consumption in healthy humans. Eur J Clin Nutr. 2003 Jan;57(1):26-30. doi: 10.1038/sj.ejcn.1601516.

    PMID: 12548293BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul VALENSI, PU/PH, Chef de service

    centre de recherche en nutrition humaine (CRNH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

FR(1)