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| Name | Class |
|---|---|
| Brightseed | INDUSTRY |
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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.
To study the impact of bioactive compound supplementation on fasting blood glucose.
To study the impact of intervention with bioactive compound on following measures of glycaemia:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Active Comparator | bioactive compound from black pepper and hemp hull |
|
| control | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCT/NFT | Dietary Supplement | extract from black pepper and hemp hull |
|
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anoop Misra | Contact | 49101222 | anoopmisra@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Diabetes, obesity and cholesterol foundation (NDOC) | Recruiting | Delhi | 110016 | India |
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double-blind placebo controlled
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Bioactive extract vs placebo