Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03221127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-04-18
First Post:
2017-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, serum, plasma, urine, hair, nails, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2682}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1984-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2052-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2052-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular disease', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of cardiovascular disease'}, {'measure': 'Carotid atherosclerosis', 'timeFrame': 'From baseline to 4-y, 11-y and 20-y examinations', 'description': 'Progression of common carotid artery - intima-media thickness (CCA-IMT)'}, {'measure': 'Death', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of death'}], 'secondaryOutcomes': [{'measure': 'Type 2 diabetes', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of type 2 diabetes'}, {'measure': 'Dementia', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of dementia'}, {'measure': 'Cancer', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of cancer'}, {'measure': 'Infectious disease', 'timeFrame': 'Annually between March 1984 and December 2052', 'description': 'Incidence of hospitalization due infectious disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Diabetes', 'Metabolic Syndrome', 'Cancer', 'Inflammatory Disease', 'Atherosclerosis', 'Cognitive Decline', 'Liver Diseases', 'Death', 'Pain, Chronic', 'Depression', 'Infection', 'Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '35652820', 'type': 'DERIVED', 'citation': 'Hockey M, Hoare E, Mohebbi M, Tolmunen T, Hantunen S, Tuomainen TP, Macpherson H, Staudacher H, Jacka FN, Virtanen JK, Rocks T, Ruusunen A. Nonfermented Dairy Intake, but Not Fermented Dairy Intake, Associated with a Higher Risk of Depression in Middle-Age and Older Finnish Men. J Nutr. 2022 Aug 9;152(8):1916-1926. doi: 10.1093/jn/nxac128.'}, {'pmid': '31360988', 'type': 'DERIVED', 'citation': 'Ylilauri MPT, Voutilainen S, Lonnroos E, Virtanen HEK, Tuomainen TP, Salonen JT, Virtanen JK. Associations of dietary choline intake with risk of incident dementia and with cognitive performance: the Kuopio Ischaemic Heart Disease Risk Factor Study. Am J Clin Nutr. 2019 Dec 1;110(6):1416-1423. doi: 10.1093/ajcn/nqz148.'}, {'pmid': '31095282', 'type': 'DERIVED', 'citation': 'Abdollahi AM, Virtanen HEK, Voutilainen S, Kurl S, Tuomainen TP, Salonen JT, Virtanen JK. Egg consumption, cholesterol intake, and risk of incident stroke in men: the Kuopio Ischaemic Heart Disease Risk Factor Study. Am J Clin Nutr. 2019 Jul 1;110(1):169-176. doi: 10.1093/ajcn/nqz066.'}, {'pmid': '30968137', 'type': 'DERIVED', 'citation': 'Virtanen HEK, Voutilainen S, Koskinen TT, Mursu J, Kokko P, Ylilauri MPT, Tuomainen TP, Salonen JT, Virtanen JK. Dietary proteins and protein sources and risk of death: the Kuopio Ischaemic Heart Disease Risk Factor Study. Am J Clin Nutr. 2019 May 1;109(5):1462-1471. doi: 10.1093/ajcn/nqz025.'}, {'pmid': '29844244', 'type': 'DERIVED', 'citation': 'Virtanen HEK, Voutilainen S, Koskinen TT, Mursu J, Tuomainen TP, Virtanen JK. Intake of Different Dietary Proteins and Risk of Heart Failure in Men: The Kuopio Ischaemic Heart Disease Risk Factor Study. Circ Heart Fail. 2018 Jun;11(6):e004531. doi: 10.1161/CIRCHEARTFAILURE.117.004531.'}], 'seeAlsoLinks': [{'url': 'https://www.uef.fi/web/nutritionepidemiologists/kuopio-ischaemic-heart-disease-risk-factor-study-kihd-1984-', 'label': 'KIHD description and timeline'}]}, 'descriptionModule': {'briefSummary': 'To determine associations between dietary factors and risk of major chronic diseases and their risk factors', 'detailedDescription': 'STUDY POPULATION The Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD) is an on-going prospective, population-based cohort study of risk factors for cardiovascular diseases, other chronic diseases and metabolic conditions in a sample of men from eastern Finland. The baseline examinations were carried out between 1984 and 1989, when 2,682 men (82.9% of those eligible) who were 42, 48, 54 or 60 years old were recruited. The first cohort consisted of 1166 men who were 54 years old, enrolled in 1984-1986, and the second cohort included 1516 men who were 42, 48, 54 or 60 years old, enrolled in 1986-1989. The baseline examinations were followed by the 4-year examinations (1991-1993), in which 1038 men from the second cohort (88% of the eligible) participated. At the 11-year examinations (1998-2001), all men from the second cohort were invited and 854 men (95% of the eligible) participated. These examinations were also the baseline for 920 postmenopausal women (78.4% of the 1173 eligible women) from the same area, aged 53-73 years. During the 20-year examination round, all men from the first and second baseline cohorts and all women were invited to the study site, and a total of 1241 men (80% of the eligible) and 634 women (81.0%) participated.\n\nASSESSMENT OF DIETARY INTAKES Food consumption has been assessed with an instructed food recording of four days, one of which was a weekend day, by household measures. A picture book of common foods and dishes was used to help in estimation of portion sizes. For each food item the participant could choose from 3-5 commonly used portion sizes or describe the portion size in relation to those in the book. In order to further improve accuracy, instructions were given and completed food records were checked by a nutritionist together with a participant. Nutrient intakes were estimated using the NUTRICA® 2.5 software (Social Insurance Institution, Turku, Finland). The databank of the software is mainly based on Finnish values of nutrient composition of foods.\n\nOUTCOME ASSESSMENT Registration of the incidence of major chronic diseases and deaths during the follow up is based on the national registries (Hospital discharge registry, Cause of death register, Social Insurance Institution of Finland register for reimbursement of medicine expenses) by use of the Finnish personal identification code (social security number), and/or on findings at the re-examination rounds (such as fasting plasma glucose or 2-h oral glucose tolerance test to define type 2 diabetes in addition to data from the national registries).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '42 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'See "Detailed description"', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)\n* Aged 53 to 73 years (women at their baseline in 1998-2001)\n* Living in the city of Kuopio or neighboring rural areas\n\nExclusion Criteria:\n\n* Condition that prevented visit at study clinic'}, 'identificationModule': {'nctId': 'NCT03221127', 'briefTitle': 'Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)', 'organization': {'class': 'OTHER', 'fullName': 'University of Eastern Finland'}, 'officialTitle': 'Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)', 'orgStudyIdInfo': {'id': 'KIHD Nutrition'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jussi Kauhanen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Eastern Finland, Institute of Public Health and Clinical Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data available for collaborative projects'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Eastern Finland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}