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

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

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 Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: NUTRIOSE FB06; Dietary supplement: GLUCIIDEX 21

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Seine-Saint-Denis
    • Bondy, Seine-Saint-Denis, France, 93143
      • CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NUTRIOSE; Group of volunteers fed with NUTRIOSE	Dietary supplement: NUTRIOSE FB06; 14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
Active Comparator: GLUCIDEX; Group of volunteers fed with GLUCIDEX	Dietary supplement: GLUCIIDEX 21; 7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satiety		D-7; D28; D56; D84
energy intake		D-7; D28; D56; D84
BMI	Body Mass Index	D-7; D28; D56; D84
body fat	measured by DEXA	D-7; D28; D56; D84
waist size		D-7; D28; D56; D84
glycemia		D-7; D28; D56; D84
insulinemia		D-7; D28; D56; D84
total cholesterol		D-7; D28; D56; D84
LDL cholesterol		D-7; D28; D56; D84
HDL cholesterol		D-7; D28; D56; D84
triglyceridemia		D-7; D28; D56; D84
HOMA	homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion)	D-7; D28; D56; D84
microbiota	measured by RT-PCR	D-7; D28; D56; D84
blood pressure		D-7; D28; D56; D84
digestive tolerance	measured with daily questionnaires	D-7; D28; D56; D84

Collaborators and Investigators

• Sponsor: Nealth Sarl
• Collaborators: Roquette Frères
• Investigators: Principal Investigator: Paul VALENSI, PU/PH, Chef de service, centre de recherche en nutrition humaine (CRNH)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 12, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: overweight; satiety; food intake; functional food; digestive tolerance
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: ROQ_NUTRIMETAB10; 2011-A00062-39 (Registry Identifier: AFSSAPS (France))