NCT01916408

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-01-01
• Completion: 2014-08-01
• First posted: 2013-08-05
• Last updated: 2015-06-30

Locations

1 site across 1 country: Germany