Open label study for Evaluation of glycemic index (GI) of Diabliss Herbal Sugar for food classification per ISO 26642 test procedure among healthy subjects
- Registration Number
- CTRI/2024/07/070733
- Lead Sponsor
- Diabliss Consumer Products Pvt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects will be enrolled if they satisfy following
Inclusion and exclusion criteria.
Age 21 to 60years male and female
Selection of a minimum of 10 healthy subjects shall be made on the basis of:
1.No known food allergy or intolerance;
2.No 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
Exclusion Criteria:
1.No known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions;
2.a major medical or surgical event requiring hospitalization within the preceding 3 months;
3.the presence of disease or drug(s) which influence digestion and absorption of nutrients;
4.the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: <br/ ><br>1.Completion of the GI test per ISO 26642 test procedure <br/ ><br> <br/ ><br>Timepoint: one week or 7 days <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary endpoints: <br/ ><br>–Safety will be assessed from the number of adverse events occurred & judging their causal relationship to the study Diabliss Herbal Sugar. <br/ ><br>Timepoint: one week or 7 days