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

NCT01621087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2012-06-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Safflower oil

Liquid safflower oil and safflower oil polyunsaturated margarine

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Christopher E Ramsden, MD · National Institutes of Health (NIH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1966-02-28
Primary Completion
1973-06-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621087 on ClinicalTrials.gov