Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-14 @ 2:26 PM
Study NCT ID:
NCT01402102
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dskim@chonbuk.ac.kr', 'phone': '82-63-250-1793', 'title': 'Dr. Dal-Sik Kim', 'organization': "Clinical trial center for Functional Food in Chonbuk Nat'l University Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and/or other \\[non-serious\\] adverse events were not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '150.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '150.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '155.8', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '156.3', 'spread': '29.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Aged garlic powder 6.0g/day oral intake'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 6.0g/day oral intake'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '46.86', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '50.81', 'spread': '9.19', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '50.36', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '50.48', 'spread': '9.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Aged garlic powder 6.0g/day oral intake'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 6.0g/day oral intake'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '139.79', 'spread': '54.55', 'groupId': 'OG000'}, {'value': '124.11', 'spread': '47.65', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '120.21', 'spread': '63.61', 'groupId': 'OG000'}, {'value': '128.11', 'spread': '65.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '241.07', 'spread': '23.97', 'groupId': 'OG000'}, {'value': '228.93', 'spread': '20.01', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '233.50', 'spread': '24.63', 'groupId': 'OG000'}, {'value': '227.33', 'spread': '32.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Apo-A1(Apolipoprotein A1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Apo-B(Apolipoprotein B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in FFA(Free Fatty Acid)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '570.25', 'spread': '193.02', 'groupId': 'OG000'}, {'value': '554.04', 'spread': '179.64', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '618.14', 'spread': '184.78', 'groupId': 'OG000'}, {'value': '523.93', 'spread': '222.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'µEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficiency of compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.', 'preAssignmentDetails': 'The criteria were an age from 20 to 80 years, a BMI(Body Mass Index)\\>23 kg/m\\^2, an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 130 and 220 mg/dL. Subjects were excluded if they had heart disease, liver or kidney disease, irregular lifestyle habits, or if they took medication and functional foods known to affect lipid metabolism'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aged Garlic Powder', 'description': 'Oral intake Aged garlic powder(6.0g/day) for 12weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral intake placebo(6.0g/day) for 12weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '8', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2011-07-21', 'resultsFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-05', 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)', 'timeFrame': '12 weeks', 'description': 'LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).'}], 'secondaryOutcomes': [{'measure': 'Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)', 'timeFrame': '12 weeks', 'description': 'HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Triglycerides', 'timeFrame': '12 weeks', 'description': 'Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Total Cholesterol', 'timeFrame': '12 weeks', 'description': 'Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Apo-A1(Apolipoprotein A1)', 'timeFrame': '12 weeks', 'description': 'Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Apo-B(Apolipoprotein B)', 'timeFrame': '12 weeks', 'description': 'Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in FFA(Free Fatty Acid)', 'timeFrame': '12 weeks', 'description': 'FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aged garlic', 'Hyperlipidemic', 'LDL', 'HDL', 'Triglyceride'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.', 'detailedDescription': 'An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild hypercholesterolemic subjects aged from 20 to 80 years\n* had no received lipid-lowering drugs for at least 3 months prior to the recruitment\n\nExclusion Criteria:\n\n* self-reported pregnancy,lactation\n* prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications'}, 'identificationModule': {'nctId': 'NCT01402102', 'briefTitle': 'A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Aged Garlic Powder on Lipids', 'orgStudyIdInfo': {'id': 'Doul-BGarlic-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aged garlic powder', 'interventionNames': ['Dietary Supplement: Aged garlic powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo powder']}], 'interventions': [{'name': 'Aged garlic powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Aged garlic powder(6.0g/day)', 'armGroupLabels': ['Aged garlic powder']}, {'name': 'Placebo powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo powder(6.0g/day)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560-822', '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}}], 'overallOfficials': [{'name': 'Dal-Sik Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}