None listed
Conditions
Interventions
Intervention1: Maltitol: Test product is a sweetner.
50 g of test Product diluted in a final volume of 150 ml of warm water which will be given to volunteers as per randomization and study design on v
Sponsors
Roquette Freres
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Digestive tolerance by self evaluation questionnaireTimepoint: 3 hours and 24 hours after test | — |
Countries
India
Contacts
Public ContactMr RB Mohile
Outcome results
None listed