Cardiovascular DiseaseNCT01216228
Food Patterns, Inflammation Markers of Cardiovascular Disease Risk and Incidence of CVD
An observational study of Cardiovascular Disease and Diet, run by Skane University Hospital.
Trial summary
Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Diet, Inflammation
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 1991to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: The Malmö Diet and Cancer Cohort (MDC), a large-scale, population-based, prospective cohort study, was designed in the early 1990s to identify dietary and lifestyle risk factors related to the incidence of cancer. Men aged 46-73 years (n =11 063) and women aged 45-73 years (n = 17 035) living in Malmö, the third largest city in Sweden, at that time, were examinedinvited to participate. Baseline examinations took place at the MDC CentreCenter at the Skåne Malmö University Hospital in Malmö between March 1991 and October 1996.
Who may be able to join
- The "cardiovascular sub-cohort" is a random sample (i.e., 50 percent) of those who joined from November 1991 to February 1994. This group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533).
Who cannot join
- Subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.
About this study
Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.
- Conditions
- Cardiovascular Disease, Diet, Inflammation
- Medical subject headings
- Cardiovascular Diseases, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startMar 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216228
- Sponsor's protocol ID
- MKC 2010-10-06
- Status last verified
- Oct 2006
- First submitted
- 6 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Patterns, Inflammation Markers of Cardiovascular Disease Risk and Incidence of CVD
- ClinicalTrials.gov ID
- NCT01216228
- Acronym / sponsor ID
- MKC 2010-10-06
- Conditions
- Cardiovascular Disease, Diet, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Mar 1991
- First posted
- 7 Oct 2010 (estimated)
- 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.
Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The Malmö Diet and Cancer Cohort (MDC), a large-scale, population-based, prospective cohort study, was designed in the early 1990s to identify dietary and lifestyle risk factors related to the incidence of cancer. Men aged 46-73 years (n =11 063) and women aged 45-73 years (n = 17 035) living in Malmö, the third largest city in Sweden, at that time, were examinedinvited to participate. Baseline examinations took place at the MDC CentreCenter at the Skåne Malmö University Hospital in Malmö between March 1991 and October 1996.
Key inclusion criteria (1 listed)
- The "cardiovascular sub-cohort" is a random sample (i.e., 50 percent) of those who joined from November 1991 to February 1994. This group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533).
Key exclusion criteria (1 listed)
- Subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Diet, run by Skane University Hospital.
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 1 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: finished, as of the sponsor's last update on 7 Oct 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 7 Oct 2010.