Red Meat, Increased Iron Load and CVD Risk

Completed

• Conditions: Stroke; Myocardial Infarction; Cardiovascular Mortality
• Interventions: Other: No intervention assigned, this is an observational study.

• Registration Number: NCT03218020
• Lead Sponsor: German Cancer Research Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 1994-09-01
• Primary Completion: 2009-12-31
• Study Completion: 2009-12-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Last Update Submitted: 2017-07-14
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25540

Inclusion Criteria

General population, age 35-65 years

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Exclusion Criteria

Prevalent myocardial infraction or stroke

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incident CVD Cases	No intervention assigned, this is an observational study.	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/).
Random Subcohort	No intervention assigned, this is an observational study.	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/).

Primary Outcome Measures

Name	Time	Method
Myocardial infraction	1994 - 2009	Incident cases of primary myocardial infarction according to clinical records
Stroke	1994 - 2009	Incident cases of primary stroke according to clinical records
Cardiovascular death	1994 - 2009	Incident cases of cardiovascular death according to death certificates

Trial Locations

Locations (1)

German Cancer Research Center; 🇩🇪 Heidelberg, Germany