Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-03-06 @ 12:43 PM
Study NCT ID:
NCT05247632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The investigators collected blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-07', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Numbers of participants with fatty liver disease', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'Fatty liver disease'}], 'primaryOutcomes': [{'measure': 'Numbers of participants with metabolic syndrome', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'metabolic syndrome'}, {'measure': 'Numbers of participants with obesity', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'Obesity'}, {'measure': 'Numbers of participants with diabetes', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'Diabetes'}], 'secondaryOutcomes': [{'measure': 'Numbers of participants died', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'All-cause and cause-specific mortality'}, {'measure': 'Numbers of participants with cardiovascular diseases', 'timeFrame': 'From entry into the study baseline:2018 until 2023', 'description': 'Cardiovascular diseases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food safety', 'Food nutrition', 'Food contaminant', 'Mult-omics', 'Chronic diseases'], 'conditions': ['Chronic Diseases']}, 'descriptionModule': {'briefSummary': 'The associations between food nutrition and safety factors with the risk of chronic diseases are still unclear. This study is conducted in Jinhua, a city with a high prevalence of chronic diseases in China, to assess relations between food nutrition and safety factors and chronic diseases.', 'detailedDescription': 'Investigations of associations of food nutrition and safety factors with the risk of chronic diseases are limited and studies in China are still lacking. The investigators aim to collect basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors, and so on, to assess the association of food nutrition and safety factors including various food items, dietary fatty acids, and internal biomarkers of food contaminants such as acrylamide and 3-MCPD with various chronic diseases in a Chinese middle-aged and elderly population. We will use multi-omics technology to investigate the causal mechanisms. Results from this study will be valuable for chronic diseases prevention in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are eligible residents from 10 government-administered units including 7 urban towns and 3 rural villages of Jinhua, China.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged ≥45 and ≤74 years old\n* Subject has complete data on diet and follow-up time\n\nExclusion Criteria:\n\nhad the major illness that had made personal life disabled'}, 'identificationModule': {'nctId': 'NCT05247632', 'acronym': 'PNFS', 'briefTitle': 'Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease (PNFS) Study', 'orgStudyIdInfo': {'id': 'Cohort-PNFS'}}, 'contactsLocationsModule': {'locations': [{'zip': '321100', 'city': 'Lanxi', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Lanxi Red Cross Hospital', 'geoPoint': {'lat': 29.21588, 'lon': 119.47156}}, {'city': 'Jinhua', 'country': 'China', 'facility': 'Lanxi Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}], 'overallOfficials': [{'name': 'Weifang Zheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lanxi Red Cross Hospital'}, {'name': 'Jingjing Jiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}, {'name': 'Yu Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}, {'name': 'Pan Zhuang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lanxi Red Cross Hospital', 'class': 'UNKNOWN'}, {'name': 'Lanxi Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yu Zhang', 'investigatorAffiliation': 'Zhejiang University'}}}}