TO EVALUATE THE GLYCEMIC AND INSULINAEMIC RESPONSES OF A TEST PRODUCT (NUTRIOSEÂ®FB06) IN HEALTHY VOLUNTEERS.

Roquette Freres0 sites20 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 27, 2013

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\.Volunteers Male / Females, Age between 20\- 60 years.
•2\.Body mass index \>18\.5 and \< 25 kg/m2 i.e. should not be overweight or obese.
•3\.Cooperating, informed of the need and duration of the study procedures, and ready to comply.
•4\.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives

•1\.Subjects with any chronic illness or any clinical condition.
•2\.Fasting glucose \>110 mg/dl.
•3\.Any chronic illness or bowel diseases in the past three months or any clinically significant ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, diabetes, crohn disease etc.
•4\.Any medication consumption in the last 2 weeks or suffering from any illness.
•5\.History of dehydration from diarrhea, vomiting or any other reason within a period of 1 week prior to the study.
•6\.Subjects with systolic blood pressure \<90 mm and \>140 mm of Hg.
•7\.Volunteers on any regular medication for any given medical illness.
•8\.An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout subjectâ??s participation in the study.
•9\.Subjects consuming more than 3 glasses of alcohol per day and /or consuming alcohol / tobacco products within 48 hours prior to dosing / during the study period or difficulty in abstaining from alcohol / tobacco product for the duration of the study.
•10\.Subject not able to moderate their level of physical activity and to refrain high physical activity before each test sessions.