Department of Preventive and Rehabilitative Sports Medicine
Munich, Bavaria, 80992, Germany
NCT Number: NCT01916408
The aim of the present study is to investigate changes in inflammatory status and incidence of infection after extreme aerobic physical stress (participation in a marathon). In addition, the impact of marathon running on the hemostasis and muscular state will be evaluated. Changes at the inflammatory, muscular, and rheological level will be related to ingestion of oral hydrolytic enzymes and bioflavonoids.
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Notify Me20 year–65 year
Male
Interventional
Phase 1
Munich, Bavaria, 80992, Germany
The influence of extreme physical stress, such as that experienced during marathon competition, on the inflammatory system and coagulation has been investigated. However, up until now, countermeasures against these adverse effects are not adequately identified.
Immune-modulators (e.g. flavonoids) are known to be present in fruits and vegetables. There are also several different proteolytic and hydrolytic enzymes found in fruits most of whom are attributed protective properties. Therefore, 160 trained and untrained runners will consume a mixture of different enzymes and flavonoids (Wobenzym Plus®) or PL 1 (placebo) and effects on changes in inflammation and hemostasiologic parameters will be investigated during and after extreme physical stress (participation in a marathon race). The clinical result of the perturbation of the immune system will be assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) with regard to symptoms of the upper respiratory tract system.
It is hypothesized that the intake of a product with immunomodulatory potential (Wobenzym Plus ®, consisting of hydrolytic enzymes and flavonoids) can positively influence both inflammation and blood coagulation pertubations observed after a marathon race.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
Other names: manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4
3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
Other names: Placebo
Time frame: one months
Change of the inflammatory marker (IL-6) before and after a marathon in relation to the consumption of oral hydrolytic enzymes and bioflavonoids.
Time frame: one months
frequency of upper respiratory tract infections (URTI) post-marathon measured by WURSS-24 questionnaire before and after the marathon
Time frame: 1 month
changes in rheological parameters (platelets,tissue plasminogen activator (tPA), plasminogen activator inhibitor (PAI-1), aggregation time)
Time frame: 1 month
changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire)
Time frame: one months
Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon
Technical University of Munich
Other
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
Acronym: Enzy-MagIC
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