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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
130
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (\>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products.
Placebo Control
Diabetes Foundation (India)
New Delhi, India
RECRUITINGFasting Blood Glucose
Blood Glucose Concentration mg/dL
Time frame: 0, and 28 days
Fasting Blood Insulin
Blood Insulin Concentration mcIU/mL
Time frame: 0, and 28 days
HbA1c
Percent (%) blood HbA1c level
Time frame: 0, and 28 days
Continuous Glucose Monitoring
Continuous Blood Glucose Monitoring mg/dL
Time frame: 0, and 28 days
Total Cholesterol
Total blood cholesterol mg/dL
Time frame: 0, and 28 days
Low-density lipoprotein (LDL) cholesterol
Blood Low-density lipoprotein (LDL) cholesterol mg/dL
Time frame: 0, and 28 days
High-density lipoprotein (HDL) cholesterol
Blood High-density lipoprotein (HDL) cholesterol mg/dL
Time frame: 0, and 28 days
Triglycerides
Blood Triglycerides mg/dL
Time frame: 0, and 28 days
Weight
kg of Body Weight
Time frame: 0, and 28 days
Height
Height in meters (m)
Time frame: 0, and 28 days
Body Mass Index (BMI)
Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters.
Time frame: 0, and 28 days
Waist Circumference
Waist Circumference in cm
Time frame: 0, and 28 days
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