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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Safflower oil
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

30 Years - 59 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Prince Henry Hospital Coronary Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safflower oil

Control group (no diet instruction)

Arm Description

Outcomes

Primary Outcome Measures

Death, all-cause

Secondary Outcome Measures

Death due to cardiovascular disease
Death due to coronary heart disease

Full Information

First Posted
June 4, 2012
Last Updated
June 15, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT01621087
Brief Title
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 1966 (undefined)
Primary Completion Date
June 1973 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safflower oil
Arm Type
Experimental
Arm Title
Control group (no diet instruction)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Safflower oil
Intervention Description
Liquid safflower oil and safflower oil polyunsaturated margarine
Primary Outcome Measure Information:
Title
Death, all-cause
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Death due to cardiovascular disease
Time Frame
Up to 7 years
Title
Death due to coronary heart disease
Time Frame
Up to 7 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Ramsden, MD
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Henry Hospital Coronary Clinic
City
Sydney
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
727035
Citation
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.
Results Reference
result
PubMed Identifier
23386268
Citation
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. Erratum In: BMJ. 2013;346:f903.
Results Reference
derived

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

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