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Completed

NCT Number: NCT03218020

Red Meat, Increased Iron Load and CVD Risk

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.

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Key information

About this study

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):

  • Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association
  • Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association
  • Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association
  • 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General population, age 35-65 years

Exclusion criteria

Prevalent myocardial infraction or stroke

Treatment and study plan

No intervention assigned, this is an observational study.

Other

No intervention assigned, this is an observational study.

Primary outcomes

  1. Myocardial infraction

    Time frame: 1994 - 2009

    Incident cases of primary myocardial infarction according to clinical records

  2. Stroke

    Time frame: 1994 - 2009

    Incident cases of primary stroke according to clinical records

  3. Cardiovascular death

    Time frame: 1994 - 2009

    Incident cases of cardiovascular death according to death certificates

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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