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

Phase 1

Completed

• Conditions: Inflammation; Death, Sudden, Cardiac; Death; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Death, Sudden; Blood Coagulation Disorders; Respiratory Tract Infections
• Interventions: Drug: Wobenzym plus; Drug: PL 1

• Registration Number: NCT01916408
• Lead Sponsor: Technical University of Munich

Brief 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.

Study Timeline

• Study First Submitted: 2013-05-15
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Primary Completion: 2014-01
• Study Completion: 2014-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wobenzym plus	Wobenzym plus	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	PL 1	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.

Primary Outcome Measures

Name	Time	Method
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Preventive and Rehabilitative Sports Medicine; 🇩🇪 Munich, Bavaria, Germany