Red Meat, Increased Iron Load and CVD Risk

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Stroke; Cardiovascular Mortality
• Intervention / Treatment: Other: No intervention assigned, this is an observational study.

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 Type: Observational
• Enrollment (Actual): 25540

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • German Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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/).	Other: No intervention assigned, this is an observational study.; 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/).	Other: No intervention assigned, this is an observational study.; No intervention assigned, this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infraction	Incident cases of primary myocardial infarction according to clinical records	1994 - 2009
Stroke	Incident cases of primary stroke according to clinical records	1994 - 2009
Cardiovascular death	Incident cases of cardiovascular death according to death certificates	1994 - 2009

Collaborators and Investigators

• Sponsor: German Cancer Research Center
• Investigators: Principal Investigator: Rudolf Kaaks, Prof., German Cancer Research Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 1994
• Primary Completion (Actual): December 31, 2009
• Study Completion (Actual): December 31, 2009

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: DKFZ Study_ID 905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No