The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon
Condition: Inflammation; Death, Sudden, Cardiac; Death; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Death, Sudden; Blood Coagulation Disorders; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Cardiovascular Diseases; Hemostatic Disorders; Death, Sudden, Cardiac; Blood Coagulation Disorders; Inflammation; Death; Pathologic Processes; Death, Sudden
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Wobenzym plus; PL 1
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4; Placebo
Intervention MeSH terms: Wobenzym
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Inflammation; Upper Respiratory Tract Illness; Oral Proteolytic and Hydrolytic Enzymes; Flavinoids