Clinical trial NCT03643094: Golden Black Seed: Support of Metabolic Health and General Wellness.
Official title: Golden Black Seed: Support of Metabolic Health and General Wellness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Hyperglycemia
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
Collaborators: name: New Chapter Inc.
First posted: 2018-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline cholesterol at 8 weeks.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline Superoxide Dismutase at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline lipid peroxidation at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline fasting glucose at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline leptin at 8 weeks.
timeFrame: 8 weeks
Other outcomes:
measure: Change from baseline Wellness at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline body composition at 8 weeks.
timeFrame: 8 weeks
measure: Change from baseline blood pressure at 8 weeks.
timeFrame: 8 weeks
Locations:
city: Klamath Falls
country: United States
facility: Gitte Jensen
state: Oregon
Study officials:
References: