The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon (Enzy-MagIC)
Primary Purpose
Inflammation, Death, Sudden, Cardiac, Death
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Wobenzym plus
PL 1
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Exercise, Inflammation, Upper Respiratory Tract Illness, Oral Proteolytic and Hydrolytic Enzymes, Flavinoids
Eligibility 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
Sites / Locations
- Department of Preventive and Rehabilitative Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Wobenzym plus
Placebo PL1
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running
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
changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire)
Full Information
NCT ID
NCT01916408
First Posted
May 15, 2013
Last Updated
June 29, 2015
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01916408
Brief Title
The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon
Acronym
Enzy-MagIC
Official Title
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Death, Sudden, Cardiac, Death, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Death, Sudden, Blood Coagulation Disorders, Respiratory Tract Infections
Keywords
Exercise, Inflammation, Upper Respiratory Tract Illness, Oral Proteolytic and Hydrolytic Enzymes, Flavinoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wobenzym plus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo PL1
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Wobenzym plus
Other Intervention Name(s)
manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PL 1
Other Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running
Description
Change of the inflammatory marker (IL-6) before and after a marathon in relation to the consumption of oral hydrolytic enzymes and bioflavonoids.
Time Frame
one months
Secondary Outcome Measure Information:
Title
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running
Description
frequency of upper respiratory tract infections (URTI) post-marathon measured by WURSS-24 questionnaire before and after the marathon
Time Frame
one months
Title
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running
Description
changes in rheological parameters (platelets,tissue plasminogen activator (tPA), plasminogen activator inhibitor (PAI-1), aggregation time)
Time Frame
1 month
Title
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running
Description
changes in muscular (CK, myoglobin)and muscular strain (McGill questionnaire)
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
The Effects of Marathon Running on cardiac biomarkers
Description
Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon
Time Frame
one months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Scherr, Dr. med.
Organizational Affiliation
Klinikum rechts der Isar der TUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Preventive and Rehabilitative Sports Medicine
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80992
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29370708
Citation
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.
Results Reference
derived
PubMed Identifier
26093876
Citation
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.
Results Reference
derived
PubMed Identifier
24559067
Citation
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.
Results Reference
derived
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The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon
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