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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT01621087

Collaborator

(none)

458

Enrollment

Location

Arms

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Feb 1, 1966

Actual Primary Completion Date :

Jun 1, 1973

Arms and Interventions

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

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

Primary Outcome Measures

Death, all-cause [Up to 7 years]

Secondary Outcome Measures

Death due to cardiovascular disease [Up to 7 years]
Death due to coronary heart disease [Up to 7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Prince Henry Hospital Coronary Clinic	Sydney		Australia

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

Investigators

Principal Investigator: Christopher E Ramsden, MD, National Institutes of Health (NIH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 18, 2012

Last Update Posted:

Jun 18, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Heart Diseases

Coronary Disease

Coronary Artery Disease

Myocardial Ischemia

Study Results

No Results Posted as of Jun 18, 2012