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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001233-40 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wobenzym plus | Active Comparator | 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. |
|
| Placebo PL1 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wobenzym plus | Drug | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Effects of Marathon Running on cardiac biomarkers | Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon | one months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Scherr, Dr. med. | Klinikum rechts der Isar der TUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Preventive and Rehabilitative Sports Medicine | Munich | Bavaria | 80992 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29370708 | Derived | Scherr J, Halle M. Amendment on the findings of two previously published articles. Eur J Prev Cardiol. 2018 Mar;25(5):558. doi: 10.1177/2047487317754279. Epub 2018 Jan 26. No abstract available. | |
| 26093876 | Derived | Grabs V, Peres T, Zelger O, Haller B, Pressler A, Braun S, Halle M, Scherr J. Decreased prevalence of cardiac arrhythmias during and after vigorous and prolonged exercise in healthy male marathon runners. Am Heart J. 2015 Jul;170(1):149-55. doi: 10.1016/j.ahj.2015.04.001. Epub 2015 Apr 9. |
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|
| PL 1 | Drug | 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. |
|
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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 |
| 24559067 | Derived | Grabs V, Nieman DC, Haller B, Halle M, Scherr J. The effects of oral hydrolytic enzymes and flavonoids on inflammatory markers and coagulation after marathon running: study protocol for a randomized, double-blind, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2014 Feb 22;6(1):8. doi: 10.1186/2052-1847-6-8. |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D016757 | Death, Sudden, Cardiac |
| D003643 | Death |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D003645 | Death, Sudden |
| D001778 | Blood Coagulation Disorders |
| D012141 | Respiratory Tract Infections |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C023295 | Wobenzym |
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