Overweight
Conditions
Keywords
overweight, satiety, functional food, food intake, digestive tolerance
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.
Interventions
DIETARY_SUPPLEMENTNUTRIOSE FB06
14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
DIETARY_SUPPLEMENTGLUCIIDEX 21
7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day
Sponsors
Roquette Freres
Nealth Sarl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight | D-7; D28; D56; D84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| energy intake | D-7; D28; D56; D84 | — |
| BMI | D-7; D28; D56; D84 | Body Mass Index |
| body fat | D-7; D28; D56; D84 | measured by DEXA |
| 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 | — |
| satiety | D-7; D28; D56; D84 | — |
| HDL cholesterol | D-7; D28; D56; D84 | — |
| triglyceridemia | D-7; D28; D56; D84 | — |
| HOMA | D-7; D28; D56; D84 | homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion) |
| microbiota | D-7; D28; D56; D84 | measured by RT-PCR |
| blood pressure | D-7; D28; D56; D84 | — |
| digestive tolerance | D-7; D28; D56; D84 | measured with daily questionnaires |
| LDL cholesterol | D-7; D28; D56; D84 | — |
Countries
France
Outcome results
None listed