None listed
Conditions
Interventions
Intervention1: Protein-Based Product 40.3g with water: Mode of Usage: Consume the protein based product 40.3g with 250 mL of water within 15 minutes.
Route of Administration: Oral
Intervention2: Prote
Sponsors
Zydus Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 45 years (both inclusive) at the time of consent 2) Sex: male and non-pregnant/non-lactating female. 3) Females of childbearing potential must have a negative urine pregnancy test performed on screening visits. 4) Subjects having fasting blood glucose levels 5) Subjects with a Body Mass Index of 18.5 to 25 kg/m2 (both inclusive). 6) Subject is in good general health as determined by the Investigator on the basis of medical history and vital signs. 7) Subjects should be willing and able to follow the study protocol to participate in the study. 8) Subject must be able to understand and provide written informed consent to participate in the study. 9) Subject is willing to refrain from vigorous physical exercise during the study period.
Exclusion criteria
Exclusion criteria: 1) Subject has any known food allergy or intolerance to any food or beverages. 2) Subject is taking any medication in the past one week. 3) Subjects should not be taking any medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable 4) Subjects should not have any known food allergy or intolerance 5) Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. 6) Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of24 hours prior to the study. 7) Subject consuming any medication in the past one week. 8) Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL. 9) 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 the subject’s participation in the study. 10) Subject has performed vigorous physical exercise in the morning on dosing day. 11) Pregnant or lactating females. 12) Self reported Positive HIV test. 13) History of Hepatitis B or C virus self-reported. Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the glycaemic index of Test foods in healthy subjects by using the in-vivo method.Timepoint: 15 minute before consumption of test food to after consumption of test food at 15, 30, 45, 60, 90 & 120 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the Calorie Index of test products containing carbohydrates using standard calculation method.Timepoint: After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23;To assess the effect of Test foods in terms of the satiety level (for hunger, fullness & desire to eat) by using visual analogue scale based subjective questionnairesTimepoint: 15 minute before consumption of test food to after consumption of test food at 30, 60, 90, 120, 180 & 240 minutes;To assess the Glycaemic Load of test products containing carbohydrates using standard calculation methodTimepoint: After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23;To assess the safety of the Test foods in terms of adverse events reported by subjects or assessed by InvestigatorTimepoint: After consumption of test food at Day 01,Day 05,Day 09,Day 16, & Day 23 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed