Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 8:50 PM
Study NCT ID:
NCT05191056
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Venous blood is sampled to measure concentrations of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)'}, {'measure': 'The change of ALT and AST', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Venous blood is sampled to measure concentrations of ALT and AST'}, {'measure': 'The change of MDA', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Venous blood is sampled to measure concentrations of MDA'}, {'measure': 'The change of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Venous blood is sampled to measure concentrations of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)'}, {'measure': 'The change of anti-aging gene expression', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Venous blood is sampled to measure expression of anti-aging gene'}, {'measure': 'The change of cardiovascular endurance', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Step test is designed to assess cardiovascular endurance'}], 'secondaryOutcomes': [{'measure': 'The change of continuous attention test', 'timeFrame': 'Days 1, 28, and 56', 'description': 'Continuous attention test is designed to assess cognitive performance'}, {'measure': 'The change of fatigue condition', 'timeFrame': 'Days 1, 28, and 56', 'description': 'BFI-Taiwan Form is collected to assess fatigue condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Antioxidative Stress']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 to 65-year-old;\n* Must read and sign the informed consent form before the experiment;\n* People who are willing to cooperate with contraception during the trial period;\n* Do not change lifestyle and eating habits arbitrarily during the trial period;\n* Do not take supplementary foods and health supplements with the same efficacy two weeks before and during the test;\n* If any adverse reaction occurs during the experiment, subjects should be notified the researcher immediately.\n\nExclusion Criteria:\n\n* Subject who is not willing to participate in this study;\n* Vegetarians;\n* People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history);\n* Participate in other clinical trials related to antioxidants and anti-aging four weeks before and during the test;\n* People with a history of dyspepsia would affect the absorption of the test product;\n* Allergic to the components of the test product;\n* Pregnant or breast-feeding women;\n* Take anti-oxidant supplements;\n* Undergoing hormone replacement therapy.'}, 'identificationModule': {'nctId': 'NCT05191056', 'briefTitle': 'Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene', 'orgStudyIdInfo': {'id': 'TSMH IRB No. 21-057-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'MelaGene drink', 'interventionNames': ['Dietary Supplement: MelaGene drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day for 8 weeks', 'armGroupLabels': ['Placebo drink']}, {'name': 'MelaGene drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day for 8 weeks', 'armGroupLabels': ['MelaGene drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '912', 'city': 'Pingtung City', 'country': 'Taiwan', 'facility': 'Bo Han Wu', 'geoPoint': {'lat': 22.67135, 'lon': 120.48814}}], 'overallOfficials': [{'name': 'Bo han Wu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pingtung University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}