NCT06454773

To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Diabetes Foundation, India · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is randomized controlled parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.

Detailed description

To study the impact of bioactive compound supplementation on fasting blood glucose. To study the impact of intervention with bioactive compound on following measures of glycaemia: * 24 hr AUC total from CGM Post-prandial glucose regulation * iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry * Fasting Insulin * HbA1c * Lipid profile Anthropometry * Weight * BMI * Waist Circumference

Conditions

• Intervention

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NCT/NFT	extract from black pepper and hemp hull

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-31
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: India