TO EVALUATE THE GLUCOSE AND INSULIN RESPONSES TO A TEST PRODUCT IN HEALTHY VOLUNTEERS
- Registration Number
- CTRI/2011/06/001789
- Lead Sponsor
- Roquette Freres
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1.Volunteers Male / Females, Age between 20- 60 years.
2.Body mass index less than 28 kg/m2 i.e. should not be 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 more than 110 mg/dl.
3.Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
4.Any medication consumption in the past one week or suffering from any illness.
5.Subjects consuming alternative system medication (Eg. Ayurvedic and Homeopathic medications).
6.History of dehydration from diarrhea, vomiting or any other reason within a period of 1 week prior to the study.
7.Subjects with systolic blood pressure le than 90 mm and more than 140 mm of Hg.
8.Volunteers on any regular medication for any given medical illness.
9.Volunteers consuming any medication in the past one week.
10.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 subject?s participation in the study.
11.Consumption of 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.
12.Volunteers with family history of diabetes
13.Volunteers with any history of food allergy
14.Subjects showing abnormal levels of BUN, creatinine, lipid profile, Liver Function test, Renal Function Test, CBC. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator?s Discretion)
15.Triglyceride more than 400 should be excluded.
16.Pregnant Women (as confirmed via UPT) and lactating women.
17.Subject likely to undergo any surgery in the period of the study
18.Subjects who were on any other experimental Investigational study within last 1 month as identified during screening.
19.Subjects unable to comply with the protocol in the opinion of Investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma glucose and insulin concentrations measurements at (time: -30 min and time: 0 min) and then at 15, 30, 45, 60, 90, 120,150, 180 min.Timepoint: Plasma glucose and insulin concentrations measurements at (time: -30 min and time: 0 min) and then at 15, 30, 45, 60, 90, 120,150, 180 min.
- Secondary Outcome Measures
Name Time Method Digestive tolerance by self evaluation questionnaireTimepoint: 3 hours and 24 hours after test