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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Golden Black Seed

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Gitte Jensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Golden Black Seed; Golden Black Seed, 1 capsule per day for 8 weeks.	Dietary supplement: Golden Black Seed; 1 capsule per day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline cholesterol at 8 weeks.	Cholesterol levels will be measured at baseline and after 8 weeks.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Superoxide Dismutase at 8 weeks.	Superoxide dismutase will be measured at baseline and after 8 weeks.	8 weeks
Change from baseline lipid peroxidation at 8 weeks.	Lipid peroxidation will be measured at baseline and after 8 weeks.	8 weeks
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
Change from baseline fasting glucose at 8 weeks.	Fasting glucose will be measured at baseline and after 8 weeks.	8 weeks
Change from baseline leptin at 8 weeks.	Leptin will be measured at baseline and after 8 weeks.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Wellness at 8 weeks.	Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10)	8 weeks
Change from baseline body composition at 8 weeks.	Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks.	8 weeks
Change from baseline blood pressure at 8 weeks.	Blood pressure will be measured at baseline and after 8 weeks.	8 weeks

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Collaborators: New Chapter Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): October 14, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperglycemia; Hyperlipidemias
• Other Study ID Numbers: 044-031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No