Cardiovascular DiseasesNCT03221127
Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)
An observational study of Cardiovascular Diseases and Diabetes, run by University of Eastern Finland.
Trial summary
To determine associations between dietary factors and risk of major chronic diseases and their risk factors Read more about this study
- Who is it for?
- Ages 42 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes, Metabolic Syndrome
- How many people
- 2,682 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 1984to 31 Dec 2052
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: See "Detailed description"
Who may be able to join
- Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
- Aged 53 to 73 years (women at their baseline in 1998-2001)
- Living in the city of Kuopio or neighboring rural areas
Who cannot join
- Condition that prevented visit at study clinic
About this study
To determine associations between dietary factors and risk of major chronic diseases and their risk factors
Read the detailed description
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.
ASSESSMENT 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.
OUTCOME 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).
- Conditions
- Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Cancer, Inflammatory Disease, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Metabolic Syndrome, Neoplasms, Atherosclerosis, Cognitive Dysfunction, Liver Diseases, Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease
Incidence of cardiovascular disease
Measured: Annually between March 1984 and December 2052
Carotid atherosclerosis
Progression of common carotid artery - intima-media thickness (CCA-IMT)
Measured: From baseline to 4-y, 11-y and 20-y examinations
Death
Incidence of death
Measured: Annually between March 1984 and December 2052
Secondary outcomes (4)
Type 2 diabetes
Incidence of type 2 diabetes
Measured: Annually between March 1984 and December 2052
Dementia
Incidence of dementia
Measured: Annually between March 1984 and December 2052
Cancer
Incidence of cancer
Measured: Annually between March 1984 and December 2052
Infectious disease
Incidence of hospitalization due infectious disease
Measured: Annually between March 1984 and December 2052
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Mar 1984
- Primary completion31 Dec 2052 (estimated)
- Study completion31 Dec 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jussi Kauhanen, MD, PhD, Principal investigator, University of Eastern Finland, Institute of Public Health and Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221127
- Sponsor's protocol ID
- KIHD Nutrition
- Status last verified
- Apr 2019
- First submitted
- 7 Jul 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available for collaborative projects
Publications
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.
PubMed 35652820Ylilauri 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.
PubMed 31360988Abdollahi 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.
PubMed 31095282Virtanen 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.
PubMed 30968137Virtanen 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.
PubMed 29844244
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)
- ClinicalTrials.gov ID
- NCT03221127
- Acronym / sponsor ID
- KIHD Nutrition
- Conditions
- Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Cancer, Inflammatory Disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,682 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 1 Mar 1984 (actual)
- Primary completion
- 31 Dec 2052 (estimated)
- Study completion
- 31 Dec 2052 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine associations between dietary factors and risk of major chronic diseases and their risk factors
Detailed description
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.
ASSESSMENT 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.
OUTCOME 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 42 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- See "Detailed description"
Key inclusion criteria (3 listed)
- Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
- Aged 53 to 73 years (women at their baseline in 1998-2001)
- Living in the city of Kuopio or neighboring rural areas
Key exclusion criteria (1 listed)
- Condition that prevented visit at study clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular disease
Time frame: Annually between March 1984 and December 2052
Incidence of cardiovascular disease
Carotid atherosclerosis
Time frame: From baseline to 4-y, 11-y and 20-y examinations
Progression of common carotid artery - intima-media thickness (CCA-IMT)
Death
Time frame: Annually between March 1984 and December 2052
Incidence of death
4 secondary outcomes
Type 2 diabetes
Time frame: Annually between March 1984 and December 2052
Dementia
Time frame: Annually between March 1984 and December 2052
Cancer
Time frame: Annually between March 1984 and December 2052
Infectious disease
Time frame: Annually between March 1984 and December 2052
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 35652820Hockey 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.
- Derived from this study: PubMed 31360988Ylilauri 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.
- Derived from this study: PubMed 31095282Abdollahi 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.
- Derived from this study: PubMed 30968137Virtanen 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.
- Derived from this study: PubMed 29844244Virtanen 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.
- KIHD description and timelineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data available for collaborative projects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jussi Kauhanen, MD, PhD principal investigator
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes, run by University of Eastern Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease (time frame: Annually between March 1984 and December 2052). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221127, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.