NCT01621087

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1966

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1973

Completed
39 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

7.3 years

First QC Date

June 4, 2012

Last Update Submit

June 15, 2012

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Death, all-cause

    Up to 7 years

Secondary Outcomes (2)

  • Death due to cardiovascular disease

    Up to 7 years

  • Death due to coronary heart disease

    Up to 7 years

Study Arms (2)

Safflower oil

EXPERIMENTAL
Other: Safflower oil

Control group (no diet instruction)

NO INTERVENTION

Interventions

Safflower oilOTHER

Liquid safflower oil and safflower oil polyunsaturated margarine

Safflower oil

Eligibility Criteria

Age30 Years - 59 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Henry Hospital Coronary Clinic

Sydney, Australia

Location

Related Publications (2)

  • 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. doi: 10.1007/978-1-4684-0967-3_18. No abstract available.

    PMID: 727035RESULT

  • Ramsden CE, Zamora D, Leelarthaepin B, Majchrzak-Hong SF, Faurot KR, Suchindran CM, Ringel A, Davis JM, Hibbeln JR. Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta-analysis. BMJ. 2013 Feb 4;346:e8707. doi: 10.1136/bmj.e8707.

    PMID: 23386268DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Safflower Oil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christopher E Ramsden, MD

    National Institutes of Health (NIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 18, 2012

Study Start

February 1, 1966

Primary Completion

June 1, 1973

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations

AU(1)