Trial | NCT03643094  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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.
Study Started
Mar 14
2018
Primary Completion
Aug 14
2018
Study Completion
Oct 14
2018
Last Update
Mar 13
2019

Dietary Supplement Golden Black Seed [nigella sativa, turmeric]

1 capsule per day for 8 weeks.

Golden Black Seed Experimental

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

Criteria 

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.
No Results Posted