None listed
Conditions
Interventions
Intervention1: Shelcal Total Vanilla with water: 25 g available carbohydrates providing test product with 250 ml of water will be consumed orally.
Single Consumption.
Intervention2: Shelcal Total Van
Sponsors
Torrent Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy, adult male and non-pregnant/non-lactating female participants between the ages of 18 to 45 years both inclusive at the time of consent. 2) Participants having fasting blood glucose levels less than 100 mg/dL. 3) Participants having HbA1c level less than 5.7 % 4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive). 5) Participants with good general health as determined by the Investigator based on medical history and vital signs. 6) Participants who are literate and can understand and provide written informed consent to participate in the study. 7) Participants who agree to refrain from vigorous physical exercise during the study period.
Exclusion criteria
Exclusion criteria: 1) Participants with any known food allergies or intolerance to any food or beverages. 2) Participants who are taking any medication for the past 4 weeks including home remedies for diabetes or ayurvedic medications or any plant extracts. 3) Pre-diabetic participants with HbA1c level of 5.7% to 6.4% and diabetic participants with HbA1c level of 6.5% or higher. 4) Participant with recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study. 5) Participants who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, intermittent fasting for two weeks prior to receiving any reference/test product and throughout participant’s participation in the study. 6) Participants who have tested positive for HIV test. 7) Participants with history of Hepatitis B or C virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the glycemic index and glycemic response of test products in healthy participants.Timepoint: 05 mins prior to product administration, 0 min and 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Satiety level using an equilateral 7-point rating scaleTimepoint: 05 mins prior to product administration and 15, 30, 60, 90 and 120 minutes post product administration on each product administration day. | — |
Countries
India
Contacts
Public ContactAltaf Makwana
Cliantha Research
Outcome results
None listed