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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

1966-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Safflower oil

Group Type EXPERIMENTAL

Safflower oil

Intervention Type OTHER

Liquid safflower oil and safflower oil polyunsaturated margarine

Control group (no diet instruction)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Safflower oil

Liquid safflower oil and safflower oil polyunsaturated margarine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
* Willingness to attend Coronary Clinic in Sydney Australia on a regular basis

Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No