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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
Sponsor:
Information provided by (Responsible Party):
Chris Ramsden, National Institutes of Health Clinical Center (CC)

Study Description
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Brief Summary:

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Safflower oil Other: Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine
No Intervention: Control group (no diet instruction)


Outcome Measures
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Primary Outcome Measures :
  1. Death, all-cause [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. Death due to cardiovascular disease [ Time Frame: Up to 7 years ]
  2. Death due to coronary heart disease [ Time Frame: Up to 7 years ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621087


Locations
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Australia
Prince Henry Hospital Coronary Clinic
Sydney, Australia
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Christopher E Ramsden, MD National Institutes of Health (NIH)
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases