Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort

July 14, 2017 updated by: University of Aarhus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stroke, including validated subtypes
Time Frame: From baseline until 30 November 2009
From baseline until 30 November 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 1993

Primary Completion (Actual)

November 30, 2009

Study Completion (Actual)

November 30, 2009

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKH-AT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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