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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator |
| |
| N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Blood Glucose Concentration mg/dL | 0, and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Insulin | Blood Insulin Concentration mcIU/mL | 0, and 28 days |
| HbA1c | Percent (%) blood HbA1c level | 0, and 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anoop Misra, PhD | Contact | 91-11-41759672 | anoopmisra@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Foundation (India) | Recruiting | New Delhi | 110 016 | India |
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|
| Placebo Control | Dietary Supplement | Placebo Control |
|
| Continuous Glucose Monitoring | Continuous Blood Glucose Monitoring mg/dL | 0, and 28 days |
| Total Cholesterol | Total blood cholesterol mg/dL | 0, and 28 days |
| Low-density lipoprotein (LDL) cholesterol | Blood Low-density lipoprotein (LDL) cholesterol mg/dL | 0, and 28 days |
| High-density lipoprotein (HDL) cholesterol | Blood High-density lipoprotein (HDL) cholesterol mg/dL | 0, and 28 days |
| Triglycerides | Blood Triglycerides mg/dL | 0, and 28 days |
| Weight | kg of Body Weight | 0, and 28 days |
| Height | Height in meters (m) | 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. | 0, and 28 days |
| Waist Circumference | Waist Circumference in cm | 0, and 28 days |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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