Clinical trial NCT03218020: Red Meat, Increased Iron Load and CVD Risk
Official title: Red Meat Consumption and Risk of Cardiovascular Diseases - is Increased Iron Load a Possible Link?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Stroke
Cardiovascular Mortality
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 25540
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke

Primary outcomes:
measure: Myocardial infraction
timeFrame: 1994 - 2009
measure: Stroke
timeFrame: 1994 - 2009
measure: Cardiovascular death
timeFrame: 1994 - 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
Study officials:
affiliation: German Cancer Research Center
name: Rudolf Kaaks, Prof.
role: PRINCIPAL_INVESTIGATOR
References: