The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon (Enzy-MagIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01916408
First received: May 15, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Inflammation
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden
Blood Coagulation Disorders
Respiratory Tract Infections
Drug: Wobenzym plus
Drug: PL 1
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running [ Time Frame: one months ] [ Designated as safety issue: No ]
    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:
  • The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running [ Time Frame: one months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire)


Other Outcome Measures:
  • The Effects of Marathon Running on cardiac biomarkers [ Time Frame: one months ] [ Designated as safety issue: No ]
    Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon


Estimated Enrollment: 160
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: 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.
Other Names:
  • Wobenzym plus
  • manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4
Placebo Comparator: Placebo PL1
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.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916408

Locations
Germany
Department of Preventive and Rehabilitative Sports Medicine
Munich, Bavaria, Germany, 80992
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Johannes Scherr, Dr. med. Klinikum rechts der Isar der TUM
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01916408     History of Changes
Other Study ID Numbers: Enzy-MaGIC2013/1, 2013-001233-40
Study First Received: May 15, 2013
Last Updated: January 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Exercise
Inflammation
Upper Respiratory Tract Illness
Oral Proteolytic and Hydrolytic Enzymes
Flavinoids

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Death
Death, Sudden
Heart Diseases
Inflammation
Pathologic Processes
Respiratory Tract Infections
Death, Sudden, Cardiac
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders
Infection
Respiratory Tract Diseases
Heart Arrest
Wobenzym
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014