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RECRUITING
NCT06454773
PHASE3

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

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

NCT/NFT

extract from black pepper and hemp hull

Locations (1)

National Diabetes, obesity and cholesterol foundation (NDOC)

Delhi, India