The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running

Conditions
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Inflammation, Death, Sudden, Cardiac, Death, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Death, Sudden, Blood Coagulation Disorders, Respiratory Tract Infections

Intervention / Treatment
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* Drug: Wobenzym plus
* Drug: PL 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Healthy male Age 20-65 years History of at least one successfully finished half marathon Intention to participate at the Munich Marathon 2013 Subject is able to read, understand, and sign a written Informed Consent to participate in the Enzy-MagIC-Study Exclusion Criteria: Known cardiac disease Known allergy against the active ingredient of the study medication or pineapple, papaya, or kiwi Known severe coagulopathy Known lactose intolerance Pharmaceutical treatment for diabetes mellitus or arterial hypertension Acute or chronic renal failure Acute or chronic liver disease Acute or chronic infection or inflammatory disease Use of medications or supplements influencing immune function Musculoskeletal or psychiatric disease Neoplasia Participation in other interventional trials

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wobenzym plus<br>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. | Drug: Wobenzym plus<br>* 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.<br>* Other names: manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4;|
| Placebo Comparator: Placebo PL1<br>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. | Drug: PL 1<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running | Change of the inflammatory marker (IL-6) before and after a marathon in relation to the consumption of oral hydrolytic enzymes and bioflavonoids. | one months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running | frequency of upper respiratory tract infections (URTI) post-marathon measured by WURSS-24 questionnaire before and after the marathon | one months | 
| The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running | changes in rheological parameters (platelets,tissue plasminogen activator (tPA), plasminogen activator inhibitor (PAI-1), aggregation time) | 1 month | 
| The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running | changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Inflammation, Upper Respiratory Tract Illness, Oral Proteolytic and Hydrolytic Enzymes, Flavinoids