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临床试验/NCT01621087
NCT01621087已完成不适用

Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2012年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
458
试验地点
1
主要终点
Death, all-cause

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 59 Years(Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Death, all-cause

时间窗: Up to 7 years

次要结局

  • Death due to cardiovascular disease(Up to 7 years)
  • Death due to coronary heart disease(Up to 7 years)

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Chris Ramsden

Clinical Investigator

National Institutes of Health Clinical Center (CC)

研究点 (1)

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