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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621087
• Other study ID #: NIHCC-E5744
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: June 15, 2012
• Start date: February 1966

Study information

• Verified date: June 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. primary completion date: June 1973
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency

• Willingness to attend Coronary Clinic in Sydney Australia on a regular basis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine

Locations

Country	Name	City	State
Australia	Prince Henry Hospital Coronary Clinic	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Woodhill JM, Palmer AJ, Leelarthaepin B, McGilchrist C, Blacket RB. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Adv Exp Med Biol. 1978;109:317-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, all-cause		Up to 7 years	No
Secondary	Death due to cardiovascular disease		Up to 7 years	No
Secondary	Death due to coronary heart disease		Up to 7 years	No