Alpha-linolenic Acid and the Risk of ASCVD

NCT ID: NCT03258983

Last Updated: 2017-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57053 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-11-24

Study Completion Date

2013-07-10

Brief Summary

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Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent.

Objectives: To investigate the associations between dietary intake of ALA, adipose tissue content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.

Methods: This project will be based on data from the Danish cohort study Diet, Cancer and Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary intake of ALA will be assessed using a validated semiquantitative food-frequency questionnaire and adipose tissue content will be determined with the use of gas chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed information on lifestyle factors, medical history and anthropometri was collected at baseline.

Incident cases have been identified through national registries and the diagnoses have previously been validated.

Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas analyses on adipose tissue content of ALA will be analysed based on a case-cohort design. Hazard ratioes with 95% confidence intervals will be used to describe the associations between the exposure variables and the outcome variables of interest.

Detailed Description

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Conditions

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Acute Myocardial Infarction Ischemic Stroke Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The Diet, Cancer and Health cohort

Alpha-linolenic acid

Intervention Type OTHER

Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.

Interventions

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Alpha-linolenic acid

Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.

Intervention Type OTHER

Other Intervention Names

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ALA (18:3-n3)

Eligibility Criteria

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Inclusion Criteria

* Born in Denmark
* Age between 50 and 64 years
* Living in the areas of Copenhagen and Aarhus

Exclusion Criteria

* Previous cancer
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Heart Foundation

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Sørensen Bork

Dr. Christian Sørensen Bork

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian S Bork, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Aalborg University Hospital, Denmark

References

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Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.

Reference Type BACKGROUND
PMID: 17786808 (View on PubMed)

Bork CS, Veno SK, Lundbye-Christensen S, Jakobsen MU, Tjonneland A, Schmidt EB, Overvad K. Dietary Intake of alpha-Linolenic Acid Is Not Appreciably Associated with Risk of Ischemic Stroke among Middle-Aged Danish Men and Women. J Nutr. 2018 Jun 1;148(6):952-958. doi: 10.1093/jn/nxy056.

Reference Type DERIVED
PMID: 29767732 (View on PubMed)

Other Identifiers

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17-R115-A7415-22060 - 2016-229

Identifier Type: -

Identifier Source: org_study_id

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