Red Meat, Increased Iron Load and CVD Risk

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218020
• Other study ID #: DKFZ Study_ID 905
• Status: Completed
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 14, 2017
• Start date: September 1, 1994
• Est. completion date: December 31, 2009

Study information

• Verified date: July 2017
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25540
• Est. completion date: December 31, 2009
• Est. primary completion date: December 31, 2009
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke

Related Conditions & MeSH terms

• Cardiovascular Mortality
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Other:
• No intervention assigned, this is an observational study.
No intervention assigned, this is an observational study.

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infraction	Incident cases of primary myocardial infarction according to clinical records	1994 - 2009
Primary	Stroke	Incident cases of primary stroke according to clinical records	1994 - 2009
Primary	Cardiovascular death	Incident cases of cardiovascular death according to death certificates	1994 - 2009