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Red Meat, Increased Iron Load and CVD Risk

2017年7月14日 更新者:German Cancer Research Center

Red Meat Consumption and Risk of Cardiovascular Diseases - is Increased Iron Load a Possible Link?

Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.

研究概览

详细说明

The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).

Here, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).

Statistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):

  1. Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association
  2. Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association
  3. Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association
  4. Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status

研究类型

观察性的

注册 (实际的)

25540

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Heidelberg、德国、69120
        • German Cancer Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 65年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

EPIC-Heidelberg was launched as part of EPIC-Europe between 1994 and 1998, when 13 611 female and 11 929 male participants aged 35 to 65 years were recruited from the local general population.

描述

Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Random Subcohort
Random subcohort (~10 % of the initial cohort, study has a case-cohort design; details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/).
No intervention assigned, this is an observational study.
Incident CVD Cases
Validated incident cases of myocardial infarction, stroke and CVD death that occured until Dec-31-2009 (details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/).
No intervention assigned, this is an observational study.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Myocardial infraction
大体时间:1994 - 2009
Incident cases of primary myocardial infarction according to clinical records
1994 - 2009
Stroke
大体时间:1994 - 2009
Incident cases of primary stroke according to clinical records
1994 - 2009
Cardiovascular death
大体时间:1994 - 2009
Incident cases of cardiovascular death according to death certificates
1994 - 2009

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rudolf Kaaks, Prof.、German Cancer Research Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

1994年9月1日

初级完成 (实际的)

2009年12月31日

研究完成 (实际的)

2009年12月31日

研究注册日期

首次提交

2017年7月13日

首先提交符合 QC 标准的

2017年7月13日

首次发布 (实际的)

2017年7月14日

研究记录更新

最后更新发布 (实际的)

2017年7月18日

上次提交的符合 QC 标准的更新

2017年7月14日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • DKFZ Study_ID 905

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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