Assessment of Glycaemic Index of test food(s) in Healthy Adult Human Subjects
- Registration Number
- CTRI/2023/08/056087
- Lead Sponsor
- Zydus Wellness Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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 <100 mg/dL.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method