Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-05-31 @ 4:28 PM
Study NCT ID:
NCT03330392
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2017-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of AGP on Immune Enhancement
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural killer cell activity', 'timeFrame': '0 week, 8 week', 'description': 'Changes of NK cell activity were assessed before and after the intervention.'}], 'secondaryOutcomes': [{'measure': 'Interleukin-1β', 'timeFrame': '0 week, 8 week', 'description': 'Changes of IL-1β were assessed before and after the intervention.'}, {'measure': 'Interleukin-6', 'timeFrame': '0 week, 8 week', 'description': 'Changes of IL-6 were assessed before and after the intervention.'}, {'measure': 'Interleukin-12 (IL-12)', 'timeFrame': '0 week, 8 week', 'description': 'Changes of IL-12 were assessed before and after the intervention.'}, {'measure': 'Interferon-γ (IFN-γ)', 'timeFrame': '0 week, 8 week', 'description': 'Changes of IFN-γ were assessed before and after the intervention.'}, {'measure': 'Tumor necrosis factor-α (TNF-α)', 'timeFrame': '0 week, 8 week', 'description': 'Changes of TNF-α were assessed before and after the intervention.'}, {'measure': 'Changes of White blood cell (WBC)', 'timeFrame': '0 week, 8 week', 'description': 'Changes of WBC were assessed before and after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Function']}, 'descriptionModule': {'briefSummary': 'The researchers investigated the immune enhancing effects of AGP for Korean participants.', 'detailedDescription': 'The aim of the study is to investigate the effects of AGP on immune enhancement based on 8 week, randomized, double-blind, placebo-controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The levels of white blood cells within range 3x10\\^3/μL\\~8x10\\^3/μL\n* have had at least two cold in the last 12 months.\n\nExclusion Criteria:\n\n* subjects with BMI\\<18.5 kg/m\\^2\n* subjects taking medications such as immune related drug or functional foods\n* history of disease that could interfere with the test products or impede their absorption\n* pregnant or lactating women and heavy smokers.\n* being judged by the responsible physician of the local study center as unfit to participate in the study'}, 'identificationModule': {'nctId': 'NCT03330392', 'briefTitle': 'Evaluation of Efficacy and Safety of AGP on Immune Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'An 8 Week, Randomized, Double-blind, Placebo-controlled Clinical Trial of AGP on Immune Enhancing Effects', 'orgStudyIdInfo': {'id': 'CTCF2_2017_AGP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGP', 'description': 'take two tablets per day (500 mg/day) for 8 weeks.', 'interventionNames': ['Dietary Supplement: AGP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'take two tablets per day for 8 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'AGP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take two tablets per day (500 mg/day) for 8 weeks', 'armGroupLabels': ['AGP']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take two tablets per day (500 mg/day) for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}