跳至主要内容
临床试验/NCT00005514
NCT00005514已完成不适用

Dietary Patterns and Risk of Cardiovascular Disease

Harvard School of Public Health (HSPH)0 个研究点目标入组 120,000 人开始时间: 1998年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120,000
主要终点
Incident cardiovascular disease

研究概览

简要总结

To study, prospectively, the association between dietary patterns and risk of coronary heart disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age 30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75 years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).

详细描述

DESIGN NARRATIVE:

In the first five years of the study analyses were performed on food consumption data collected through semiquantitative food frequency questionnaires at baseline and during follow-up in the Nurses Health Study and Health Professionals Follow-up Study cohorts. Dietary patterns were derived from the food consumption data using factor analysis, cluster analysis, and dietary indexes (based on prevailing dietary recommendations). In addition, using existing datasets from dietary validation studies in sub-samples of the two cohorts, the reproducibility and validity of dietary patterns defined by factor/cluster analysis and dietary indexes were evaluated. Further, using prospectively collected and stored bloods in the NHS (n-32,826) during 1989-1990 and the HPFS (n-18,000) during 1993-1994, the investigators examined whether observed associations between dietary patterns and CHD were explained by (or mediated through) plasma biochemical measurements (including serum lipids, thrombotic factors, antioxidants, fasting insulin, and homocysteine levels) in a nested case-control design; and they assessed prospectively the relationship between dietary patterns and these biomarkers in the control samples.

The study was renewed in 2005 to apply novel statistical methods (such as confirmatory factor analysis and structural equation modeling) to validate various dietary patterns and examine their associations with risk of type 2 diabetes, cardiovascular disease and total mortality in two large ongoing cohort studies, the Nurses' Health Study (n=121,700) and Health Professionals' Follow-up Study (n=51,529). In addition to evaluating prevailing dietary recommendations, the study will also examine the role of the Mediterranean-type dietary pattern, the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and the Atkins-type diet in predicting health outcomes. Using repeated measurements of diet, the study will examine the impact of changes in eating patterns and diet quality over time on subsequent risk of diabetes, CVD, and total mortality. In addition, it will examine relationships between major dietary patterns and novel plasma biomarkers of inflammation and endothelial function and whether such relationships are mediated through obesity. Finally, the study will test interactions between dietary patterns and individual single nucleotide polymorphisms (SNPs) and haplotypes of several promising candidate genes in the inflammation and endothelial dysfunction pathway on risk of coronary heart disease, including PPARa, PPARy, Adiponectin (AdipoQ), PON1, IL-6, TNF-a, ICAM-1, VCAM-1, E-Selectin, NOS3, ACE gene, and angiotensinogen (ANG) genes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incident cardiovascular disease

时间窗: 1980-2008

Myocardial infarction, fatal coronary disease, and stroke documented by medical records

次要结局

未报告次要终点

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank B. Hu

Professor

Harvard School of Public Health (HSPH)

相似试验

Dietary Patterns and Risk of Cardiovascular Disease | 临床试验