Impact of GLUBLOC™ on postprandial blood glucose and insulin levels.
- Registration Number
- CTRI/2023/08/056330
- Lead Sponsor
- My Pura Vida Wellness Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Aged between 18–60 years,
BMI between 20 and 29.9 kg/m2
Fasting blood glucose = 5.7 mmol/l (or) = 99 mg/dl
History of hypersensitivity to any of the investigational product, excipients, or Any known food allergies.
Pre-existing medical condition or taking medication known to affect glucose regulation and/or influence digestion and absorption of nutrients
History of diabetes mellitus (type I/II) or they used antihyperglycemic drugs or insulin to treat diabetes or related conditions
Use steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
Subjects with the history of uncontrolled hypertension and/or hyperthyroidism.
History of alcoholism
Subjects with psychiatric or neurological disability or mental health disorder
Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.
Subjects who refuse to sign informed consent.
According to the investigator’s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of GLUBLOC on postprandial changes in blood glucose & insulin levels post carbohydrate rich mealTimepoint: On the day of intervention, Blood glucose levels will be measured at t0 (fasting), post meal measurements at t30, t60, t90 & t120 minutes through a finger prick glucose test with AccuChek Active glucometer F. Hoffmann La Roche AG. Venous blood sample of 3 ml will be collected at t60 min timepoint & used to assess serum insulin levels.
- Secondary Outcome Measures
Name Time Method To assess if the subjects experience flatulence or bloating during the study.Timepoint: T60 & T120 min during the study.