Back to resultsGolden Black Seed: Support of Metabolic Health and General Wellness.
Primary Purpose
Hyperlipidemias, Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Golden Black Seed
Sponsored by
About this trial
This is an interventional basic science trial for Hyperlipidemias
Eligibility 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.
Sites / Locations
- Gitte Jensen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Golden Black Seed
Arm Description
Golden Black Seed, 1 capsule per day for 8 weeks.
Outcomes
Primary Outcome Measures
Change from baseline cholesterol at 8 weeks.
Cholesterol levels will be measured at baseline and after 8 weeks.
Secondary Outcome Measures
Change from baseline Superoxide Dismutase at 8 weeks.
Superoxide dismutase will be measured at baseline and after 8 weeks.
Change from baseline lipid peroxidation at 8 weeks.
Lipid peroxidation will be measured at baseline and after 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.
Change from baseline fasting glucose at 8 weeks.
Fasting glucose will be measured at baseline and after 8 weeks.
Change from baseline leptin at 8 weeks.
Leptin will be measured at baseline and after 8 weeks.
Full Information
NCT ID
NCT03643094
First Posted
March 13, 2018
Last Updated
March 11, 2019
Sponsor
Natural Immune Systems Inc
Collaborators
New Chapter Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03643094
Brief Title
Golden Black Seed: Support of Metabolic Health and General Wellness.
Official Title
Golden Black Seed: Support of Metabolic Health and General Wellness.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
October 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natural Immune Systems Inc
Collaborators
New Chapter Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Hyperglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Golden Black Seed
Arm Type
Experimental
Arm Description
Golden Black Seed, 1 capsule per day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Golden Black Seed
Intervention Description
1 capsule per day for 8 weeks.
Primary Outcome Measure Information:
Title
Change from baseline cholesterol at 8 weeks.
Description
Cholesterol levels will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Superoxide Dismutase at 8 weeks.
Description
Superoxide dismutase will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Title
Change from baseline lipid peroxidation at 8 weeks.
Description
Lipid peroxidation will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Title
Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.
Description
8-OHdG will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Title
Change from baseline fasting glucose at 8 weeks.
Description
Fasting glucose will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Title
Change from baseline leptin at 8 weeks.
Description
Leptin will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline Wellness at 8 weeks.
Description
Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10)
Time Frame
8 weeks
Title
Change from baseline body composition at 8 weeks.
Description
Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks.
Time Frame
8 weeks
Title
Change from baseline blood pressure at 8 weeks.
Description
Blood pressure will be measured at baseline and after 8 weeks.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Gitte Jensen
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Golden Black Seed: Support of Metabolic Health and General Wellness.
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