Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT04104308
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Egg and Dietary Cholesterol Consumption With Mortality and Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The blood samples were collected in 2009 for the first time'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33453}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'participants were followed up from 1991 to 2015', 'description': 'mortality'}], 'secondaryOutcomes': [{'measure': 'metabolic syndrome', 'timeFrame': 'The blood samples were collected in 2009 for the first time.', 'description': 'MetS was defined according to the updated National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATP III) criteria for Asian-Americans.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mets', 'Death']}, 'referencesModule': {'references': [{'pmid': '34506988', 'type': 'DERIVED', 'citation': 'Wu F, Zhuang P, Zhan C, Shen X, Jiao J, Zhang Y. Egg and Dietary Cholesterol Consumption and the Prevalence of Metabolic Syndrome: Findings from a Population-Based Nationwide Cohort. J Acad Nutr Diet. 2022 Apr;122(4):758-770.e5. doi: 10.1016/j.jand.2021.09.010. Epub 2021 Oct 11.'}, {'pmid': '32307193', 'type': 'DERIVED', 'citation': 'Zhuang P, Jiao J, Wu F, Mao L, Zhang Y. Egg and egg-sourced cholesterol consumption in relation to mortality: Findings from population-based nationwide cohort. Clin Nutr. 2020 Nov;39(11):3520-3527. doi: 10.1016/j.clnu.2020.03.019. Epub 2020 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'To assess the associations between egg and dietary cholesterol consumption with mortality and metabolic syndrome (MetS).', 'detailedDescription': 'Substitution models, sensitivity analyses, subgroup analyses and multiple linear regression analyses will be conducted to specifically estimate the hazard ratios and 95% confidence intervals of mortality and MetS associated with egg and cholesterol consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The CHNS is a nationwide cohort survey in China, which was established as a joint project of the University of North Carolina at Chapel and the China Center for Disease Control and Prevention (CCDC).This national-wide survey adopted a novel measure from multiple dimensions, which helped to understand how the long-term social and economic changes affected nutrition and health-related outcomes of Chinese. Until now, 10 rounds of survey (1989, 1991, 1993, 1997, 2000, 2004, 2006, 2009, 2011 and 2015) have been conducted.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants aged ≥20 y\n\nExclusion Criteria:\n\n* missing creatinine, age, cannot be linked to socio-demographic data; aged less than 20; without complete dietary data .'}, 'identificationModule': {'nctId': 'NCT04104308', 'briefTitle': 'Association of Egg and Dietary Cholesterol Consumption With Mortality and Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Association of Egg and Dietary Cholesterol Consumption With Mortality and Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'Cohort_egg_mortality'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jingjing Jiao', 'investigatorAffiliation': 'Zhejiang University'}}}}