Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Inflammatory marker: Interleukin 6 and Interleukin 10
Study Overview
Brief Summary
The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. The investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. Furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.
Detailed Description
Regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders.
Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.
We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.
Diagnostic tools include measurements of microvasculature, the large vessels and echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and interleukins.
All variations are analysed on the basis of consumption of polyphenols as they are found in in hops (Humulus lupus L.) and beer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •men aged 20-60 years
Exclusion Criteria
- •manifested heart disease
- •insulin dependent diabetes mellitus
- •multi drug therapy
- •GFR < 60 ml/min
- •neoplasia
- •(former) alcoholism
- •known malabsorption
- •known chronic inflammatory disease
Outcomes
Primary Outcomes
Inflammatory marker: Interleukin 6 and Interleukin 10
Time Frame: pre-, post-, one & three day follow-up
Secondary Outcomes
- E/E' ratio(pre-, post-, one & three day follow-up)
- AV-ratio(pre-, post-, one & three day follow-up)