To assess the positive Impact of a nutraceutical (GLUBLOC™ granules) on postprandial blood glucose levels when taken along with the carbohydrate rich meal
- Registration Number
- CTRI/2024/01/061799
- 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
- 107
Aged between 18 to 60 years
BMI between 18.5 and 29.9 kg per m2
Fasting blood glucose greater than 70 mg per dl and less than or equal to 99 mg per 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 or influence digestion and absorption of nutrients
History of diabetes mellitus (type I or II) or they used antihyperglycemic drugs or insulin to treat diabetes or related conditions
Used 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 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.
Subjects who donot have basic understanding of English language, which include speaking or writing in English.
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 investigators 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™ granules on postprandial changes in blood glucose levels post carbohydrate rich meal intake.Timepoint: Time points: t0 (fasting), t30, t60, t90 and t120 minutes on Day 1 & Day 5.
- Secondary Outcome Measures
Name Time Method Observation of Adverse events during the study periodTimepoint: Day 1 & Day 5