Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chris Ramsden, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01621087
First received: June 4, 2012
Last updated: June 15, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Death, all-cause [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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: NCT01621087

Locations
Australia
Prince Henry Hospital Coronary Clinic
Sydney, Australia
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher E Ramsden, MD National Institutes of Health (NIH)
  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
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014