None listed
Conditions
Interventions
Intervention1: Complan VieMax Vanilla with water: Test product with 250 ml of water will be consumed orally. Single Consumption.
Intervention2: Complan VieMax Vanilla with milk: Test product with 200
Sponsors
Zydus Wellness Products Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects having fasting blood glucose levels more than 100 mg/dL. 2) Subjects having HbA1c level more than 5.7% 3) Subjects with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive). 4) Subjects who can understand and provide written informed consent to participate in the study. 5) Subjects who are willing to refrain from vigorous physical exercise during the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects with any known food allergy or intolerance to any food or beverages. 2) Subjects who are taking any medication for past one week including home remedies for diabetes or ayurvedic medications or any plant extracts. 3) Pre-diabetic subjects with HbA1c level of 5.7% to 6.4% and diabetic subjects with HbA1c level of 6.5% or higher. 4) Subjects with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study. 5) Subjects who have participated in any clinical trial within the past 90 days with blood loss more than 450 ml. 6) Subjects who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, for two weeks prior to receiving any reference/test product and throughout subject’s participation in the study. 7) Subjects having history of Hepatitis B or C virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To determine the glycemic index of test products (when consumed with water), in healthy subjects. 2) To determine the glycemic response of test products (when consumed with milk), in healthy subjects.Timepoint: 15 mins prior to product administration and 0, 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: 15 mins prior to product administration and 0, 30, 60, 90 and 120 minutes post product administration on each product administration day. | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed