Status:
COMPLETED
Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects
Lead Sponsor:
Nealth Sarl
Collaborating Sponsors:
Roquette Freres
Conditions:
Overweight
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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 solu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01897662
Start Date
April 1 2012
End Date
June 1 2013
Last Update
July 12 2013
Active Locations (1)
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1
CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier
Bondy, Seine-Saint-Denis, France, 93143