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

Study Overview
=================
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.

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

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: NUTRIOSE FB06
* Dietary Supplement: GLUCIIDEX 21


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUTRIOSE<br>Group of volunteers fed with NUTRIOSE | Dietary Supplement: NUTRIOSE FB06<br>* 14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day<br>|
| Active Comparator: GLUCIDEX<br>Group of volunteers fed with GLUCIDEX | Dietary Supplement: GLUCIIDEX 21<br>* 7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, satiety, functional food, food intake, digestive tolerance