None listed
Conditions
Interventions
Intervention1: NUTRIOSE®FB06: The test product (NUTRIOSE®FB06) is a sweetner. 50 g of test Product diluted in a final volume of 250 ml of cool water which will be given to volunteers as per randomiz
Sponsors
Roquette Freres
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers Male / Females, Age between 20- 60 years. 2. Body mass index >18.5 and 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 >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 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. 11. Subject not able to fast for 12 hours overnight before each test sessions. 12. Subjects who consume more than 3 glasses of alcohol per day 13. Subjects who donâ??t want to limit its consumption of isabgol (psyllium seed husk), wheat bran and similar types of fibers for 48 hours before the study. 14. Subjects who consume dietary supplements like probiotics or prebiotics. 15. Volunteers with family history of diabetes 16. Volunteers with any history of food allergy 17. Subjects with abnormal BUN, Creatinine, and Liver Function Tests as seen by Biochemical evaluation on the screening visit (unless otherwise decided by Investigator). 18. Subjects showing abnormal levels CBC. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigatorâ??s Discretion) 19. Pregnant Women (as confirmed via UPT) and lactating women. 20. Subject likely to undergo any surgery in the period of the study 21. Subjects who were on any other experimental Investigational study within last 1 month as identified during screening. 22. Subjects unable to comply with the protocol in the opinion of Investigators. 23. Subjects consuming alternative system medication (E.g. Ayurvedic and Homeopathic medications) for improving digestion, managing constipation and manage blood sugar levels. 24. Serum Triglycerides > 400 mg/dl should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose and insulin concentrations measurements atTimepoint: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 min | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Glycemic and insulinaemic responses of NUTRIOSE®FB06 compared to glucose measured from 0 to 120 minutes and from 0 to 180 minutesTimepoint: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 min | — |
Countries
India
Contacts
Public ContactMr R BMohile
C.L.A.I.M.S. Pvt. Ltd.
Outcome results
None listed