Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT05988593
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of Match to sample test', 'timeFrame': 'Change from Baseline match to sample test value at 8 weeks', 'description': 'The number of memorized cards was utilized to measure Match to sample test value.'}, {'measure': 'The change of Trail making test', 'timeFrame': 'Change from Baseline Trail making test value at 8 weeks', 'description': 'The time of finishing actions was utilized to measure Trail making test value.'}, {'measure': 'The change of Processing speed test', 'timeFrame': 'Change from Baseline Processing speed test value at 8 weeks', 'description': 'The number of pressing buttons was utilized to measure Processing speed test value.'}, {'measure': 'The change of Mnemonic Similarity Task', 'timeFrame': 'Change from Baseline Mnemonic Similarity Task value at 8 weeks', 'description': 'The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.'}, {'measure': 'The change of facial expression cuing task', 'timeFrame': 'Change from Baseline facial expression cuing task value at 8 weeks', 'description': 'The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.'}, {'measure': 'The change of State-trait anxiety inventory', 'timeFrame': 'Change from Baseline State-trait anxiety inventory value at 8 weeks', 'description': 'The scores of anxiety state was utilized to measure State-trait anxiety inventory value.'}, {'measure': 'The change of score of fatigue', 'timeFrame': 'Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks', 'description': 'The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.'}, {'measure': 'The change of score of life quality', 'timeFrame': 'Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks', 'description': 'The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of MelaGene+ on cognitive performance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 65-year-old males or females\n\nExclusion Criteria:\n\n* Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)\n* Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)\n* Participants take drugs for a long time (self-report)\n* Participants with mental illness or have undergone brain surgery\n* Participants still can not clearly see words with 12pt on computer after corrected vision'}, 'identificationModule': {'nctId': 'NCT05988593', 'briefTitle': 'Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink', 'orgStudyIdInfo': {'id': 'CMUH111-REC3-127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo drink', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MelaGene+', 'interventionNames': ['Dietary Supplement: MelaGene+']}], 'interventions': [{'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume one bottle (30 mL) per day', 'armGroupLabels': ['placebo drink']}, {'name': 'MelaGene+', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Melaleuca-MelaGene+'], 'description': 'consume one bottle (30 mL) per day', 'armGroupLabels': ['MelaGene+']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Jing-Ling Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}