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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643094
• Other study ID #: 044-031
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: October 14, 2018

Study information

• Verified date: March 2018
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Golden Black Seed
1 capsule per day for 8 weeks.

Locations

Country	Name	City	State
United States	Gitte Jensen	Klamath Falls	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Natural Immune Systems Inc	New Chapter Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Wellness at 8 weeks.	Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10)	8 weeks
Other	Change from baseline body composition at 8 weeks.	Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks.	8 weeks
Other	Change from baseline blood pressure at 8 weeks.	Blood pressure will be measured at baseline and after 8 weeks.	8 weeks
Primary	Change from baseline cholesterol at 8 weeks.	Cholesterol levels will be measured at baseline and after 8 weeks.	8 weeks
Secondary	Change from baseline Superoxide Dismutase at 8 weeks.	Superoxide dismutase will be measured at baseline and after 8 weeks.	8 weeks
Secondary	Change from baseline lipid peroxidation at 8 weeks.	Lipid peroxidation will be measured at baseline and after 8 weeks.	8 weeks
Secondary	Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.	8-OHdG will be measured at baseline and after 8 weeks.	8 weeks
Secondary	Change from baseline fasting glucose at 8 weeks.	Fasting glucose will be measured at baseline and after 8 weeks.	8 weeks
Secondary	Change from baseline leptin at 8 weeks.	Leptin will be measured at baseline and after 8 weeks.	8 weeks