Impact of GLUBLOC™ on postprandial blood glucose and insulin levels.

A Prospective, Randomised, Placebo Controlled Study to Evaluate the Impact of GLUBLOC™ on postprandial blood glucose and insulin levels in healthy individuals post high carbohydrate meal intake. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056330

Enrollment

Registered

2023-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: GLUBLOC: GLUBLOC Tablet is Nutraceutical proprietary blend of Morus alba L extract and Malus domestical peel extract (350 mg) along with the FSSAI approved excipients Microcrystalline C

Eligibility

Inclusion criteria

Inclusion criteria: Aged between 18–60 years, BMI between 20 and 29.9 kg/m2 Fasting blood glucose = 5.7 mmol/l (or) = 99 mg/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 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.

Design outcomes

Secondary

Measure	Time frame
To assess if the subjects experience flatulence or bloating during the study.Timepoint: T60 & T120 min during the study.	—

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

India

Contacts

Public ContactDr Chaitanya Chakravarthi Gali

My Pura Vida Wellness Pvt Ltd

g.ch.chakravarthi@gmail.com9391752535

Outcome results