StrokeNCT03220568
Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort
An observational study of Stroke, run by University of Aarhus.
Trial summary
Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear. Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Stroke
- What is being tested?
- Fatty acids present in adipose tissue samples
- How many people
- 57,053 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 1993to 30 Nov 2009
- 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 50 to 64 years
- All sexes
- Adult
Study population: Between 1993 and 1997, a total of 57,053 men and women were recruited. At the time of invitation, they were 50 to 64 years old, born in Denmark, residing in the urban and suburban areas of Copenhagen and Aarhus and had not been registered with a cancer diagnosis in the Danish Cancer Registry.
Inclusion Criteria: Born in Denmark, aged 50-64 years, residing in the urban and suburban areas of Copenhagen and Aarhus, Denmark.
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Exclusion Criteria: Pre-existing cancer diagnosis. Previous stroke.
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About this study
Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.
Objective: Therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.
Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health cohort, including all incident stroke cases and a random sample of the total cohort.The fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. Stroke cases were identified in the Danish National Patient Registry and the diagnoses were individually verified. Cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.
- Conditions
- Stroke
- Being tested
- Fatty acids present in adipose tissue samples
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty acids present in adipose tissue samplesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke, including validated subtypes
Measured: From baseline until 30 November 2009
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 start24 Nov 1993
- Primary completion30 Nov 2009
- Study completion30 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 57,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220568
- Sponsor's protocol ID
- KKH-AT
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort
- ClinicalTrials.gov ID
- NCT03220568
- Acronym / sponsor ID
- KKH-AT
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57,053 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 24 Nov 1993 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- 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.
Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.
Objective: Therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.
Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health cohort, including all incident stroke cases and a random sample of the total cohort.The fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. Stroke cases were identified in the Danish National Patient Registry and the diagnoses were individually verified. Cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Between 1993 and 1997, a total of 57,053 men and women were recruited. At the time of invitation, they were 50 to 64 years old, born in Denmark, residing in the urban and suburban areas of Copenhagen and Aarhus and had not been registered with a cancer diagnosis in the Danish Cancer Registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatty acids present in adipose tissue samples | Other | – |
Primary outcome
Stroke, including validated subtypes
Time frame: From baseline until 30 November 2009
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 18 Jul 2017.
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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 Stroke, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Jul 2017. 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.
What does the primary outcome measure?
Stroke, including validated subtypes (time frame: From baseline until 30 November 2009). It is what the study was designed to measure, not a finding.
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 18 Jul 2017.