Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
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Purpose
The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction. However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973) was a randomized controlled secondary CHD prevention trial testing whether selectively increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A full analysis of mortality outcomes has not been published. The investigators recovered the original SDHS dataset, which included detailed longitudinal dietary, smoking and coded mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.
Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed mortality differences.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Other: Safflower oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial |
- Death, all-cause [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Death due to cardiovascular disease [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Death due to coronary heart disease [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
| Enrollment: | 458 |
| Study Start Date: | February 1966 |
| Primary Completion Date: | June 1973 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Safflower oil |
Other: Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine
|
| No Intervention: Control group (no diet instruction) |
Eligibility| Ages Eligible for Study: | 30 Years to 59 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
- Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
Contacts and Locations
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chris Ramsden, Clinical Investigator, National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01621087 History of Changes |
| Other Study ID Numbers: | NIHCC-E5744 |
| Study First Received: | June 4, 2012 |
| Last Updated: | June 15, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013