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| Name | Class |
|---|---|
| Brightseed, Inc | UNKNOWN |
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This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94 apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline) and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones, serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health, quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite, satiety, and cravings will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo is maltodextrin, delivered as 2 capsules. |
|
| Active | Active Comparator | The active comparator is black pepper extract, delivered as 2 capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black pepper extract | Dietary Supplement | Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1 |
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| Measure | Description | Time Frame |
|---|---|---|
| waist circumference | measurement of waist circumference in centimeters | Change from baseline to week 12 |
| triglycerides | measurement of triglycerides in blood | Change from baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| urinary ketones | ketone concentration in urine | Change from baseline to week 12 |
| plasma free fatty acids | concentration of free fatty acids in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite | appetite as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings. | Change from baseline to week 12 |
| Satiety | satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater satiety. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change from baseline to week 12 |
| body weight | body weight measurement in kg | Change from baseline to week 12 |
| Body mass index | body mass index (body weight relative to height) | Change from baseline to week 12 |
| liver enzymes | fasting levels of ALT and AST measured in international units per liter (IU/L) | Change from baseline to week 12 |
| Change from baseline to week 12 |
| Cravings | cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings. | Change from baseline to week 12 |
| Short Form Health Survey (SF-36) | health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status. | Chnage from baseline to week 12 |