None listed
Conditions
Interventions
Intervention1: Glubloc™ tablet: 500mg/ Day Total Duration 1
days (Day 1 and Day 5)
Control Intervention1: Tablet with Filler (Cellulose) and binding agent: 500mg/ Day Total Duration 1
days (Day 1 and
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Aged between 18 to 60 years, •BMI between 20 and 29.9 kg per m2 •Fasting blood glucose less than 6.1 mmol per l (or) less than 99 mg per dl
Exclusion criteria
Exclusion criteria: •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 nutrient of diabetes mellitus type I and 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 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 •Those who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period •According to the investigator’s opinion participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To assess the impact of GLUBLOC™ on postprandial changes in blood glucose levels post carbohydrate rich meal •To assess the impact of GLUBLOC™ on postprandial changes on insulin levels post carbohydrate rich mealTimepoint: •Time points t0 fasting, t30, t60, t90 and t120 minutes on Day 1 and Day 5 •Time points t60 on Day 1 and Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| •To assess if the subjects feel sustained energy levels post supplementation period at t60 & t120 minutes Day 1 & Day 5 •To evaluate any experience of gas & bloating post treatment period at t60 & t120 minutes Day 1 & Day 5 •To evaluate the safety of GLUBLOC™ in terms of a. Any hypoglycemic event during the supplementation period Day 1 & Day 5 b Any other AE occurring during the study period Throughout the study period Timepoint: At t60 & t120 minutes Day 1 & Day 5 At t60 & t120 minutes Day 1 & Day 5 a Day 1 & Day 5 b Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Sujay Gowda
My Pura Vida Wellness Pvt Ltd.
Outcome results
None listed