HyperlipidemiasNCT03643094
Golden Black Seed: Support of Metabolic Health and General Wellness.
A study testing Golden Black Seed in people with Hyperlipidemias and Hyperglycemia, run by Natural Immune Systems Inc at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Hyperglycemia
- What is being tested?
- Golden Black Seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult people of either gender;
- Age 40-75 years (inclusive);
- BMI 25-34.9 (inclusive);
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Golden Black Seed
- Medical subject headings
- Hyperlipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golden Black SeedDietary supplement
1 capsule per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Golden Black Seed | Experimental | Golden Black Seed, 1 capsule per day for 8 weeks. Receives: Dietary Supplement: Golden Black Seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cholesterol at 8 weeks.
Cholesterol levels will be measured at baseline and after 8 weeks.
Measured: 8 weeks
Secondary outcomes (5)
Change from baseline Superoxide Dismutase at 8 weeks.
Superoxide dismutase will be measured at baseline and after 8 weeks.
Measured: 8 weeks
Change from baseline lipid peroxidation at 8 weeks.
Lipid peroxidation will be measured at baseline and after 8 weeks.
Measured: 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.
Measured: 8 weeks
Change from baseline fasting glucose at 8 weeks.
Fasting glucose will be measured at baseline and after 8 weeks.
Measured: 8 weeks
Change from baseline leptin at 8 weeks.
Leptin will be measured at baseline and after 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start14 Mar 2018
- Primary completion14 Aug 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Collaborators
- New Chapter Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643094
- Sponsor's protocol ID
- 044-031
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golden Black Seed: Support of Metabolic Health and General Wellness.
- ClinicalTrials.gov ID
- NCT03643094
- Acronym / sponsor ID
- 044-031
- Conditions
- Hyperlipidemias, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Collaborators
- New Chapter Inc.
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Golden Black Seed | Experimental | Dietary Supplement: Golden Black SeedGolden Black Seed, 1 capsule per day for 8 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult people of either gender;
- Age 40-75 years (inclusive);
- BMI 25-34.9 (inclusive);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golden Black Seed1 capsule per day for 8 weeks. | Dietary supplement | Golden Black Seed |
Primary outcome
Change from baseline cholesterol at 8 weeks.
Time frame: 8 weeks
Cholesterol levels will be measured at baseline and after 8 weeks.
5 secondary outcomes
Change from baseline Superoxide Dismutase at 8 weeks.
Time frame: 8 weeks
Change from baseline lipid peroxidation at 8 weeks.
Time frame: 8 weeks
Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.
Time frame: 8 weeks
Change from baseline fasting glucose at 8 weeks.
Time frame: 8 weeks
Change from baseline leptin at 8 weeks.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golden Black Seed in people with Hyperlipidemias and Hyperglycemia, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cholesterol at 8 weeks. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.