Hyperglycemia, Hyperlipidemias
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTGolden Black Seed
1 capsule per day for 8 weeks.
Sponsors
New Chapter Inc.
Natural Immune Systems Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult people of either gender; 2. Age 40-75 years (inclusive); 3. BMI 25-34.9 (inclusive);
Exclusion criteria
1. Cancer during past 12 months; 2. Chemotherapy during past 12 months; 3. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder); 4. 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; 5. Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed; 6. Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease); 7. Currently experiencing intense stressful events or life changes; 8. Currently in intensive athletic training (such as marathon runners); 9. Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant; 10. Known food allergies or sensitivities related to the test products or placebo; 11. History of drug abuse during past two years; 12. Participation in another clinical trial involving a consumable test product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline cholesterol at 8 weeks. | 8 weeks | Cholesterol levels will be measured at baseline and after 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline lipid peroxidation at 8 weeks. | 8 weeks | Lipid peroxidation will be measured at baseline and after 8 weeks. |
| Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks. | 8 weeks | 8-OHdG will be measured at baseline and after 8 weeks. |
| Change from baseline fasting glucose at 8 weeks. | 8 weeks | Fasting glucose will be measured at baseline and after 8 weeks. |
| Change from baseline leptin at 8 weeks. | 8 weeks | Leptin will be measured at baseline and after 8 weeks. |
| Change from baseline Superoxide Dismutase at 8 weeks. | 8 weeks | Superoxide dismutase will be measured at baseline and after 8 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline body composition at 8 weeks. | 8 weeks | Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks. |
| Change from baseline Wellness at 8 weeks. | 8 weeks | Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10) |
| Change from baseline blood pressure at 8 weeks. | 8 weeks | Blood pressure will be measured at baseline and after 8 weeks. |
Countries
United States
Outcome results
None listed