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

Natural Immune Systems

Status: Completed

Conditions: Hyperglycemia; Hyperlipidemias

Treatments: Dietary Supplement: Golden Black Seed

Study type: Interventional

Funder types: Other

Identifiers

NCT03643094

044-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Golden Black Seed

Experimental group

Description:

Golden Black Seed, 1 capsule per day for 8 weeks.

Treatment:

Dietary Supplement: Golden Black Seed