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| Name | Class |
|---|---|
| New Chapter Inc. | UNKNOWN |
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To document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic health and wellness in human subjects.
Golden Black Seed contains extracts from the turmeric root (Curcuma longa) and black cumin seeds (Nigella sativa). Both botanicals have been used traditionally in Asian cooking, and also in herbal medicine for reducing inflammation.
For this clinical study, human participants will be tested over a period of 8 weeks. Below is a simplified diagram illustrating the involvement of each human subject, where all study participants will be tested on three different clinic days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golden Black Seed | Experimental | Golden Black Seed, 1 capsule per day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golden Black Seed | Dietary Supplement | 1 capsule per day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cholesterol at 8 weeks. | Cholesterol levels will be measured at baseline and after 8 weeks. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Superoxide Dismutase at 8 weeks. | Superoxide dismutase will be measured at baseline and after 8 weeks. | 8 weeks |
| Change from baseline lipid peroxidation at 8 weeks. | Lipid peroxidation will be measured at baseline and after 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Wellness at 8 weeks. | Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10) | 8 weeks |
| Change from baseline body composition at 8 weeks. | Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gitte Jensen | Klamath Falls | Oregon | 97601 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
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| 8 weeks |
| Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks. | 8-OHdG will be measured at baseline and after 8 weeks. | 8 weeks |
| Change from baseline fasting glucose at 8 weeks. | Fasting glucose will be measured at baseline and after 8 weeks. | 8 weeks |
| Change from baseline leptin at 8 weeks. | Leptin will be measured at baseline and after 8 weeks. | 8 weeks |
| 8 weeks |
| Change from baseline blood pressure at 8 weeks. | Blood pressure will be measured at baseline and after 8 weeks. | 8 weeks |
| D044882 | Glucose Metabolism Disorders |