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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
Sponsor: Diabetes Foundation, India
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.
Key Details
Gender
All
Age Range
25 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-06-01
Completion Date
2024-12-31
Last Updated
2024-06-12
Healthy Volunteers
Yes
Conditions
Interventions
NCT/NFT
extract from black pepper and hemp hull
Locations (1)
National Diabetes, obesity and cholesterol foundation (NDOC)
Delhi, India