Alpha-linolenic Acid and the Risk of ASCVD
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03258983 |
|
Recruitment Status :
Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Acute Myocardial Infarction Ischemic Stroke Peripheral Artery Disease | Other: Alpha-linolenic acid |
| Study Type : | Observational |
| Actual Enrollment : | 57053 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease |
| Actual Study Start Date : | November 24, 1993 |
| Actual Primary Completion Date : | July 10, 2013 |
| Actual Study Completion Date : | July 10, 2013 |
| Group/Cohort | Intervention/treatment |
|---|---|
| The Diet, Cancer and Health cohort |
Other: 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.
Other Name: ALA (18:3-n3) |
- Incident acute myocardial infarction [ Time Frame: From baseline until July 2013 ]
- Incident ischemic stroke including total and subtypes of ischemic stroke [ Time Frame: From baseline until November 2009 ]
- Incident peripheral artery disease [ Time Frame: From baseline until December 2009 ]
- Incident fatal myocardial infarction [ Time Frame: From baseline until July 2013 ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993 and 1997 by inviting 160,725 men and women to participate. All eligible participants were native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the Diet, Cancer and Health cohort study.
A subcohort of 3500 participants were drawn randomly from the cohort at baseline.
Inclusion Criteria:
- Born in Denmark
- Age between 50 and 64 years
- Living in the areas of Copenhagen and Aarhus
Exclusion Criteria:
- Previous cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258983
| Principal Investigator: | Christian S Bork, MD | Department of Cardiology, Aalborg University Hospital, Denmark |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Christian Sørensen Bork, Dr. Christian Sørensen Bork, Aalborg University Hospital |
| ClinicalTrials.gov Identifier: | NCT03258983 History of Changes |
| Other Study ID Numbers: |
17-R115-A7415-22060 - 2016-229 |
| First Posted: | August 23, 2017 Key Record Dates |
| Last Update Posted: | August 23, 2017 |
| Last Verified: | August 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Alpha-linolenic acid Dietary intake Adipose tissue Nutritional epidemiology |
|
Myocardial Infarction Peripheral Arterial Disease Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Peripheral Vascular Diseases |