Actively Recruiting
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
Led by Diabetes Foundation, India · Updated on 2024-06-12
130
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
D
Diabetes Foundation, India
Lead Sponsor
B
Brightseed
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prediabetic individuals with BMI between 25 and 30 kg/m2
- Waist circumference of at least 80 cm for women and at least 90 cm for men
- Fasting blood glucose between 100 and 125 mg/dL
- Age between 25 and 60 years
You will not qualify if you...
- Weight change of 4.5 kg or more within 90 days before study start
- Use of weight loss medications within 90 days before study start
- History of gastrointestinal surgery or cosmetic procedures for weight/fat reduction
- Use of dietary supplements affecting weight or appetite within 30 days before study start
- History of extreme dietary habits
- History of diagnosed eating disorders
- Current diagnosis of type 1 or type 2 diabetes
- HbA1c level of 48 mmol/mol (6.5%) or higher at initial visit
- History of chronic gastrointestinal disorders except mild lactose intolerance or gastroesophageal reflux
- Signs or symptoms of active infection within 5 days before study start
- Pregnancy, planning pregnancy, lactation, or unwillingness to use approved contraception during study
- Any condition interfering with informed consent, protocol compliance, or study safety
- Excessive alcohol consumption (more than 2 drinks or 60 ml whisky per day)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Diabetes, obesity and cholesterol foundation (NDOC)
Delhi, India, 110016
Actively Recruiting
Research Team
A
Anoop Misra
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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