Golden Black Seed: Support of Metabolic Health and General Wellness.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Golden Black Seed: Support of Metabolic Health and General Wellness.

Conditions
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Hyperlipidemias, Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Golden Black Seed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult people of either gender; Age 40-75 years (inclusive); BMI 25-34.9 (inclusive); Exclusion Criteria: Cancer during past 12 months; Chemotherapy during past 12 months; Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder); Currently consuming large doses of anti-inflammatory nutritional supplements, and unwilling to stop taking these supplements for 2 weeks prior to and during the study; Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed; Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease); Currently experiencing intense stressful events or life changes; Currently in intensive athletic training (such as marathon runners); Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant; Known food allergies or sensitivities related to the test products or placebo; History of drug abuse during past two years; Participation in another clinical trial involving a consumable test product.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Golden Black Seed<br>Golden Black Seed, 1 capsule per day for 8 weeks. | Dietary Supplement: Golden Black Seed<br>* 1 capsule per day for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cholesterol at 8 weeks. | Cholesterol levels will be measured at baseline and after 8 weeks. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |