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

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ClinicalTrials.gov Identifier: NCT03220568
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

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.


Condition or disease Intervention/treatment
Stroke Other: Fatty acids present in adipose tissue samples

Study Type : Observational
Actual Enrollment : 57053 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort
Actual Study Start Date : November 24, 1993
Actual Primary Completion Date : November 30, 2009
Actual Study Completion Date : November 30, 2009



Primary Outcome Measures :
  1. Stroke, including validated subtypes [ Time Frame: From baseline until 30 November 2009 ]

Biospecimen Retention:   Samples With DNA
Subcutaneous adipose tissue


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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes 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.
Criteria

Inclusion Criteria: Born in Denmark, aged 50-64 years, residing in the urban and suburban areas of Copenhagen and Aarhus, Denmark.

Exclusion Criteria: Pre-existing cancer diagnosis. Previous stroke.


Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03220568     History of Changes
Other Study ID Numbers: KKH-AT
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases