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

NCT ID: NCT03643094

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2018-10-14

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.

Conditions

Hyperlipidemias; Hyperglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Golden Black Seed

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

Group Type: EXPERIMENTAL

Golden Black Seed

Intervention Type: DIETARY_SUPPLEMENT

1 capsule per day for 8 weeks.

Interventions

Golden Black Seed

1 capsule per day for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Chapter Inc.

UNKNOWN

Sponsor Role: collaborator

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gitte Jensen

Klamath Falls, Oregon, United States

Countries

United States

Other Identifiers

044-031

Identifier Type: -

Identifier Source: org_study_id