Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-21 @ 11:34 PM
Study NCT ID:
NCT03643094
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2018-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Golden Black Seed: Support of Metabolic Health and General Wellness.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline Wellness at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Wellness Questionnaire will be administered at baseline and 8 weeks (scales 0-10)'}, {'measure': 'Change from baseline body composition at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Dexa scan for fat mass (kg) will be performed at baseline and 8 weeks.'}, {'measure': 'Change from baseline blood pressure at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Blood pressure will be measured at baseline and after 8 weeks.'}], 'primaryOutcomes': [{'measure': 'Change from baseline cholesterol at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Cholesterol levels will be measured at baseline and after 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Superoxide Dismutase at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Superoxide dismutase will be measured at baseline and after 8 weeks.'}, {'measure': 'Change from baseline lipid peroxidation at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Lipid peroxidation will be measured at baseline and after 8 weeks.'}, {'measure': 'Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.', 'timeFrame': '8 weeks', 'description': '8-OHdG will be measured at baseline and after 8 weeks.'}, {'measure': 'Change from baseline fasting glucose at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Fasting glucose will be measured at baseline and after 8 weeks.'}, {'measure': 'Change from baseline leptin at 8 weeks.', 'timeFrame': '8 weeks', 'description': 'Leptin will be measured at baseline and after 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemias', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'To document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic health and wellness in human subjects.\n\nGolden 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult people of either gender;\n2. Age 40-75 years (inclusive);\n3. BMI 25-34.9 (inclusive);\n\nExclusion Criteria:\n\n1. Cancer during past 12 months;\n2. Chemotherapy during past 12 months;\n3. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder);\n4. 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;\n5. Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;\n6. Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);\n7. Currently experiencing intense stressful events or life changes;\n8. Currently in intensive athletic training (such as marathon runners);\n9. Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant;\n10. Known food allergies or sensitivities related to the test products or placebo;\n11. History of drug abuse during past two years;\n12. Participation in another clinical trial involving a consumable test product.'}, 'identificationModule': {'nctId': 'NCT03643094', 'briefTitle': 'Golden Black Seed: Support of Metabolic Health and General Wellness.', 'organization': {'class': 'OTHER', 'fullName': 'Natural Immune Systems Inc'}, 'officialTitle': 'Golden Black Seed: Support of Metabolic Health and General Wellness.', 'orgStudyIdInfo': {'id': '044-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Golden Black Seed', 'description': 'Golden Black Seed, 1 capsule per day for 8 weeks.', 'interventionNames': ['Dietary Supplement: Golden Black Seed']}], 'interventions': [{'name': 'Golden Black Seed', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule per day for 8 weeks.', 'armGroupLabels': ['Golden Black Seed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97601', 'city': 'Klamath Falls', 'state': 'Oregon', 'country': 'United States', 'facility': 'Gitte Jensen', 'geoPoint': {'lat': 42.22487, 'lon': -121.78167}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Immune Systems Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Chapter Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}