Coronary Heart DiseaseNCT01621087
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
A study testing Safflower oil in people with Coronary Heart Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, men only
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Safflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 1966to Jun 1973
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
- Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial
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
- Coronary Heart Disease
- Being tested
- Safflower oil
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safflower oilOther
Liquid safflower oil and safflower oil polyunsaturated margarine
| Study group | Role | What they receive |
|---|---|---|
| Safflower oil | Experimental | Not described Receives: Other: Safflower oil |
| Control group (no diet instruction) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, all-cause
Measured: Up to 7 years
Secondary outcomes (2)
Death due to cardiovascular disease
Measured: Up to 7 years
Death due to coronary heart disease
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startFeb 1966
- Primary completionJun 1973
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Chris Ramsden, National Institutes of Health Clinical Center (CC)
- Investigators
- Christopher E Ramsden, MD, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621087
- Sponsor's protocol ID
- NIHCC-E5744
- Status last verified
- Jun 2012
- First submitted
- 4 Jun 2012
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 727035Ramsden 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.
PubMed 23386268
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial
- ClinicalTrials.gov ID
- NCT01621087
- Acronym / sponsor ID
- NIHCC-E5744
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Feb 1966
- Primary completion
- Jun 1973 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safflower oil | Experimental | Other: Safflower oil |
| Control group (no diet instruction) | No intervention | – |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
- Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safflower oilLiquid safflower oil and safflower oil polyunsaturated margarine | Other | Safflower oil |
Primary outcome
Death, all-cause
Time frame: Up to 7 years
2 secondary outcomes
Death due to cardiovascular disease
Time frame: Up to 7 years
Death due to coronary heart disease
Time frame: Up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
- Results publication: PubMed 727035Woodhill 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.
- Derived from this study: PubMed 23386268Ramsden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Ramsden, MD principal investigator
National Institutes of Health (NIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safflower oil in people with Coronary Heart Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, all-cause (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2012.