Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 4:02 AM
Study NCT ID:
NCT01534533
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Lutein Supplementation on Subclinical Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'C563733', 'term': 'Carotid Intimal Medial Thickness 1'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'harveyzou2002@bjmu.edu.cn', 'phone': '+8610-13581525193', 'title': 'Dr. Zhiyong Zou', 'organization': 'Peking University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'adverse event data were collected in 12months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lutein Group', 'description': 'early atherosclerosis cases, received 20mg lutein, once a day', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combination Group', 'description': 'early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Normal Lutein Control Group', 'description': '20mg lutein for subjects free from atherosclerosis, once a day', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Table 1 Study Specific Characteristic Part One', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (P Group)', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'OG001', 'title': 'Lutein Group (L Group)', 'description': 'early atherosclerosis case received 20mg lutein'}, {'id': 'OG002', 'title': 'Lutein and Lycopene Group (LL Group)', 'description': 'received 20mg lutein and 20mg lycopene'}, {'id': 'OG003', 'title': 'Normal Lutein Control Group (NL Group)', 'description': 'subjects free from atherosclerosis received 20mg lutein'}], 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '59.8', 'groupId': 'OG001'}, {'value': '59.1', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}]}]}, {'title': 'Race (Han people)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension history', 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}, {'value': '56.8', 'groupId': 'OG002'}, {'value': '20.9', 'groupId': 'OG003'}]}]}, {'title': 'Diabetes history', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}, {'value': '25.6', 'groupId': 'OG003'}]}]}, {'title': 'Hyperlipemia history', 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '65.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05 (two sides)', 'groupDescription': 'The null hypothesis was "no group difference"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': 'The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted a per protocol analysis of all the subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Table 1 Study Specific Characteristic of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (P Group)', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'OG001', 'title': 'Lutein Group (L Group)', 'description': 'early atherosclerosis case received 20mg lutein'}, {'id': 'OG002', 'title': 'Combination Group (LL Group)', 'description': 'received 20mg lutein and 20mg lycopene'}, {'id': 'OG003', 'title': 'Normal Lutein Control Group (NL Group)', 'description': 'subjects free from atherosclerosis received 20mg lutein'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '57.3', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '53.8', 'spread': '5.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.992', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05 (two sides)', 'groupDescription': 'The null hypothesis was "no group difference"', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline', 'description': 'the mean and standard deviation of age was calculated in four groups', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted a per protocol analysis of all the subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Table 1 Study Specific Characteristic of Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (P Group)', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'OG001', 'title': 'Lutein Group (L Group)', 'description': 'early atherosclerosis case received 20mg lutein'}, {'id': 'OG002', 'title': 'Combination Group (LL Group)', 'description': 'received 20mg lutein and 20mg lycopene'}, {'id': 'OG003', 'title': 'Normal Lutein Control Group (NL Group)', 'description': 'subjects free from atherosclerosis received 20mg lutein'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '24.1', 'spread': '2.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.672', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05 (two sides)', 'groupDescription': 'The null hypothesis was "no group difference"', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline', 'description': 'the mean and standard deviation of BMI in four groups was calculated', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted a per protocol analysis of all the subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Table 1 Study Specific Characteristic of Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (P Group)', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'OG001', 'title': 'Lutein Group (L Group)', 'description': 'early atherosclerosis case received 20mg lutein'}, {'id': 'OG002', 'title': 'Lutein and Lycopene Group (LL Group)', 'description': 'received 20mg lutein and 20mg lycopene'}, {'id': 'OG003', 'title': 'Normal Lutein Control Group (NL Group)', 'description': 'subjects free from atherosclerosis received 20mg lutein'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '129.7', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '125.5', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '126.0', 'spread': '15.5', 'groupId': 'OG002'}, {'value': '117.7', 'spread': '11.9', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '82.6', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '80.5', 'spread': '9.6', 'groupId': 'OG002'}, {'value': '77.2', 'spread': '8.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.402', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05 (two sides)', 'groupDescription': 'The null hypothesis was "no group difference"', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline', 'description': 'systolic BP and diastolic BP in four groups was measure twice between 15minutes', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted a per protocol analysis of all the subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Table 1 Study Specific Characteristic of Serum Carotenoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (P Group)', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'OG001', 'title': 'Lutein Group (L Group)', 'description': 'early atherosclerosis case received 20mg lutein'}, {'id': 'OG002', 'title': 'Combination Group (LL Group)', 'description': 'early atherosclerosis cases received 20mg lutein and 20mg lycopene'}, {'id': 'OG003', 'title': 'Normal Lutein Control Group (NL Group)', 'description': 'subjects free from atherosclerosis received 20mg lutein'}], 'classes': [{'title': 'Lutein', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '0.11', 'groupId': 'OG003'}]}]}, {'title': 'Zeaxanthin', 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.035', 'spread': '0.022', 'groupId': 'OG002'}, {'value': '0.030', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'beta-carotene', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.069', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '0.071', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '0.058', 'spread': '0.005', 'groupId': 'OG003'}]}]}, {'title': 'Lycopene', 'categories': [{'measurements': [{'value': '0.106', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.092', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.104', 'spread': '0.074', 'groupId': 'OG002'}, {'value': '0.098', 'spread': '0.038', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.636', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05 (two sides)', 'groupDescription': 'The null hypothesis was "no group difference"', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline', 'description': 'serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)', 'unitOfMeasure': 'μg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted a per protocol analysis of all the subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months', 'timeFrame': 'at baseline and after 12 months', 'description': 'Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '3333-12'}, {'type': 'SECONDARY', 'title': 'Dietary Intake of Energy During the Study Periods', 'timeFrame': 'at baseline and 12 months', 'description': 'Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '3333-12'}, {'type': 'SECONDARY', 'title': 'Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods', 'timeFrame': 'at baseline and 12 months', 'description': 'Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '3333-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'FG001', 'title': 'Lutein Group', 'description': '20mg lutein per day'}, {'id': 'FG002', 'title': 'Lutein and Lycopene Group', 'description': 'lutein plus lycopene group'}, {'id': 'FG003', 'title': 'Normal Lutein Group', 'description': 'subjects without early atherosclerosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules'}, {'id': 'BG001', 'title': 'Lutein Group', 'description': '20mg lutein per day'}, {'id': 'BG002', 'title': 'Lutein and Lycopene Group', 'description': 'lutein plus lycopene group'}, {'id': 'BG003', 'title': 'Normal Lutein Group', 'description': 'subjects without early atherosclerosis'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '53.8', 'spread': '5.8', 'groupId': 'BG003'}, {'value': '56.5', 'spread': '5.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2012-02-13', 'resultsFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-13', 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Table 1 Study Specific Characteristic Part One', 'timeFrame': 'at baseline', 'description': 'The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.'}, {'measure': 'Table 1 Study Specific Characteristic of Age', 'timeFrame': 'at baseline', 'description': 'the mean and standard deviation of age was calculated in four groups'}, {'measure': 'Table 1 Study Specific Characteristic of Body Mass Index (BMI)', 'timeFrame': 'at baseline', 'description': 'the mean and standard deviation of BMI in four groups was calculated'}, {'measure': 'Table 1 Study Specific Characteristic of Blood Pressure (BP)', 'timeFrame': 'at baseline', 'description': 'systolic BP and diastolic BP in four groups was measure twice between 15minutes'}, {'measure': 'Table 1 Study Specific Characteristic of Serum Carotenoids', 'timeFrame': 'at baseline', 'description': 'serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)'}], 'secondaryOutcomes': [{'measure': 'Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months', 'timeFrame': 'at baseline and after 12 months', 'description': 'Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).'}, {'measure': 'Dietary Intake of Energy During the Study Periods', 'timeFrame': 'at baseline and 12 months', 'description': 'Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.'}, {'measure': 'Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods', 'timeFrame': 'at baseline and 12 months', 'description': 'Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['early atherosclerosis', 'serum lutein', 'serum lycopene', 'intima-media thickness', 'arterial stiffness', 'combined effect'], 'conditions': ['Carotid Atherosclerosis', 'Carotid Intimal Medial Thickness 1']}, 'referencesModule': {'references': [{'pmid': '21872250', 'type': 'BACKGROUND', 'citation': 'Zou Z, Xu X, Huang Y, Xiao X, Ma L, Sun T, Dong P, Wang X, Lin X. High serum level of lutein may be protective against early atherosclerosis: the Beijing atherosclerosis study. Atherosclerosis. 2011 Dec;219(2):789-93. doi: 10.1016/j.atherosclerosis.2011.08.006. Epub 2011 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.', 'detailedDescription': 'Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of which are the top two causes of death in industrialized countries including China. Lutein was found to be protective against atherosclerosis in some case control studies. However, the intervention on atherosclerosis have not been reported. In the present study, 192 subjects were randomly assigned to four groups treated with different amounts of lutein. The investigators observe the changes of serum lutein concentration by hyper-pressure liquid chromatography (HPLC), and compare the differences of common carotid IMT and arterial stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7 and 12 months of treatment by auto-analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* early atherosclerosis;\n* aged 45 to 68 years;\n* Han nationality\n\nExclusion Criteria:\n\n* history of myocardial infarction,\n* stroke,\n* revascularization,\n* coronary by-pass operation,\n* local carotid IMT \\> 1300μm or supplemental vitamin and/or mineral use for ≥ 4 week before the start of the study'}, 'identificationModule': {'nctId': 'NCT01534533', 'briefTitle': 'Effects of Lutein Supplementation on Subclinical Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Effects of Lutein Supplementation on Subclinical Atherosclerosis', 'orgStudyIdInfo': {'id': 'NNSFC-30972472'}, 'secondaryIdInfos': [{'id': 'XLin', 'type': 'REGISTRY', 'domain': 'XLin'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lutein group', 'description': 'early atherosclerosis cases, received 20mg lutein, once a day', 'interventionNames': ['Dietary Supplement: Lutein group']}, {'type': 'EXPERIMENTAL', 'label': 'Combination group', 'description': 'early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day', 'interventionNames': ['Dietary Supplement: Combination group']}, {'type': 'EXPERIMENTAL', 'label': 'Normal lutein control group', 'description': '20mg lutein for subjects free from atherosclerosis, once a day', 'interventionNames': ['Dietary Supplement: Normal lutein control group']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing starch per day, for 12 months', 'armGroupLabels': ['Placebo']}, {'name': 'Lutein group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 20mg lutein per day, for 12 months', 'armGroupLabels': ['Lutein group']}, {'name': 'Combination group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months', 'armGroupLabels': ['Combination group']}, {'name': 'Normal lutein control group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months', 'armGroupLabels': ['Normal lutein control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Haidian District', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaoming Lin, M.M.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoming Lin', 'investigatorAffiliation': 'Peking University'}}}}