Actively Recruiting
To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
Led by Brightseed · Updated on 2024-07-24
130
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is randomized placebo controlled, double-blinded, 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 a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fasting blood glucose between 100 and 125 mg/dL
- Body mass index (BMI) between 25 and 30 kg/m2
- Waist circumference at least 80 cm for women and at least 90 cm for men
You will not qualify if you...
- Weight change of 4.5 kg or more within 90 days before the first visit
- Use of weight loss medications within 90 days before the first visit
- History of gastrointestinal surgery or cosmetic procedures for weight/fat reduction
- Use of dietary supplements that may affect weight loss or appetite within 30 days before the first visit
- History of extreme dietary habits as judged by the investigator
- Diagnosed eating disorders such as anorexia nervosa, bulimia nervosa, or binge eating
- Current diagnosis of type 1 or type 2 diabetes mellitus
- HbA1c level of 48 mmol/mol (6.5%) or higher at the first visit
- History of chronic gastrointestinal disorders except mild lactose intolerance or acid reflux
- Signs or symptoms of an active infection within 5 days before the first visit
- Pregnancy, planning pregnancy, lactation, or unwillingness to use approved contraception during the study
- Any condition interfering with consent, protocol compliance, or study interpretation
- Excessive alcohol consumption of more than 2 drinks (60 ml whisky) per day
AI-Screening
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Trial Site Locations
Total: 1 location
1
Diabetes Foundation (India)
New Delhi, India, 110 016
Actively Recruiting
Research Team
A
Anoop Misra, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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