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Completed

NCT Number: NCT01916408

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Preventive and Rehabilitative Sports Medicine

Munich, Bavaria, 80992, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4

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.

Other names: Placebo

Primary outcomes

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

    Time frame: 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 outcomes

  1. The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running

    Time frame: one months

    frequency of upper respiratory tract infections (URTI) post-marathon measured by WURSS-24 questionnaire before and after the marathon

  2. The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running

    Time frame: 1 month

    changes in rheological parameters (platelets,tissue plasminogen activator (tPA), plasminogen activator inhibitor (PAI-1), aggregation time)

  3. The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running

    Time frame: 1 month

    changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire)

Other outcomes

  1. The Effects of Marathon Running on cardiac biomarkers

    Time frame: one months

    Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: Enzy-MagIC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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