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

Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01621087
Enrollment
458
Registered
2012-06-18
Start date
1966-02-28
Completion date
Unknown
Last updated
2012-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

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.

Interventions

Liquid safflower oil and safflower oil polyunsaturated margarine

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
MALE
Age
30 Years to 59 Years
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

Design outcomes

Primary

MeasureTime frame
Death, all-causeUp to 7 years

Secondary

MeasureTime frame
Death due to cardiovascular diseaseUp to 7 years
Death due to coronary heart diseaseUp to 7 years

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026