Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
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ClinicalTrials.gov Identifier: NCT01621087 |
Recruitment Status :
Completed
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Other: Safflower oil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 458 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | February 1966 |
Actual Primary Completion Date : | June 1973 |

Arm | Intervention/treatment |
---|---|
Experimental: Safflower oil |
Other: Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine |
No Intervention: Control group (no diet instruction) |
- Death, all-cause [ Time Frame: Up to 7 years ]
- Death due to cardiovascular disease [ Time Frame: Up to 7 years ]
- Death due to coronary heart disease [ Time Frame: Up to 7 years ]

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Ages Eligible for Study: | 30 Years to 59 Years (Adult) |
Sexes 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

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): NCT01621087
Australia | |
Prince Henry Hospital Coronary Clinic | |
Sydney, Australia |
Principal Investigator: | Christopher E Ramsden, MD | National Institutes of Health (NIH) |
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 |
Other Study ID Numbers: |
NIHCC-E5744 |
First Posted: | June 18, 2012 Key Record Dates |
Last Update Posted: | June 18, 2012 |
Last Verified: | June 2012 |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |