Clinical trial NCT01897662: Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects
Official title: Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: overweight
satiety
functional food
food intake
digestive tolerance
Lead sponsor: Nealth Sarl
Sponsor class: NETWORK
Collaborators: name: Roquette Freres
First posted: 2013-07-12
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
measure: body weight
timeFrame: D-7; D28; D56; D84
Secondary outcomes:
measure: satiety
timeFrame: D-7; D28; D56; D84
measure: energy intake
timeFrame: D-7; D28; D56; D84
measure: BMI
timeFrame: D-7; D28; D56; D84
measure: body fat
timeFrame: D-7; D28; D56; D84
measure: waist size
timeFrame: D-7; D28; D56; D84
measure: glycemia
timeFrame: D-7; D28; D56; D84
measure: insulinemia
timeFrame: D-7; D28; D56; D84
measure: total cholesterol
timeFrame: D-7; D28; D56; D84
measure: LDL cholesterol
timeFrame: D-7; D28; D56; D84
measure: HDL cholesterol
timeFrame: D-7; D28; D56; D84
measure: triglyceridemia
timeFrame: D-7; D28; D56; D84
measure: HOMA
timeFrame: D-7; D28; D56; D84
measure: microbiota
timeFrame: D-7; D28; D56; D84
measure: blood pressure
timeFrame: D-7; D28; D56; D84
measure: digestive tolerance
timeFrame: D-7; D28; D56; D84
Other outcomes:
Locations:
city: Bondy
country: France
facility: CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier
state: Seine-Saint-Denis
Study officials:
affiliation: centre de recherche en nutrition humaine (CRNH)
name: Paul VALENSI, PU/PH, Chef de service
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.