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OpenTrials
Completed

NCT Number: NCT03643094

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gitte Jensen

Klamath Falls, Oregon, 97601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Golden Black Seed

Dietary Supplement

1 capsule per day for 8 weeks.

Primary outcomes

  1. Change from baseline cholesterol at 8 weeks.

    Time frame: 8 weeks

    Cholesterol levels will be measured at baseline and after 8 weeks.

Secondary outcomes

  1. Change from baseline Superoxide Dismutase at 8 weeks.

    Time frame: 8 weeks

    Superoxide dismutase will be measured at baseline and after 8 weeks.

  2. Change from baseline lipid peroxidation at 8 weeks.

    Time frame: 8 weeks

    Lipid peroxidation will be measured at baseline and after 8 weeks.

  3. Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.

    Time frame: 8 weeks

    8-OHdG will be measured at baseline and after 8 weeks.

  4. Change from baseline fasting glucose at 8 weeks.

    Time frame: 8 weeks

    Fasting glucose will be measured at baseline and after 8 weeks.

  5. Change from baseline leptin at 8 weeks.

    Time frame: 8 weeks

    Leptin will be measured at baseline and after 8 weeks.

Other outcomes

  1. Change from baseline Wellness at 8 weeks.

    Time frame: 8 weeks

    Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10)

  2. Change from baseline body composition at 8 weeks.

    Time frame: 8 weeks

    Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks.

  3. Change from baseline blood pressure at 8 weeks.

    Time frame: 8 weeks

    Blood pressure will be measured at baseline and after 8 weeks.

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Collaborators

  • New Chapter Inc.

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2018
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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