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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
76
14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day
CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier
Bondy, Seine-Saint-Denis, France
body weight
Time frame: D-7; D28; D56; D84
satiety
Time frame: D-7; D28; D56; D84
energy intake
Time frame: D-7; D28; D56; D84
BMI
Body Mass Index
Time frame: D-7; D28; D56; D84
body fat
measured by DEXA
Time frame: D-7; D28; D56; D84
waist size
Time frame: D-7; D28; D56; D84
glycemia
Time frame: D-7; D28; D56; D84
insulinemia
Time frame: D-7; D28; D56; D84
total cholesterol
Time frame: D-7; D28; D56; D84
LDL cholesterol
Time frame: D-7; D28; D56; D84
HDL cholesterol
Time frame: D-7; D28; D56; D84
triglyceridemia
Time frame: D-7; D28; D56; D84
HOMA
homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion)
Time frame: D-7; D28; D56; D84
microbiota
measured by RT-PCR
Time frame: D-7; D28; D56; D84
blood pressure
Time frame: D-7; D28; D56; D84
digestive tolerance
measured with daily questionnaires
Time frame: D-7; D28; D56; D84
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