Clinical trial NCT01916408: The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon
Official title: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 160
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running
timeFrame: one months
Secondary outcomes:
measure: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running
timeFrame: one months
measure: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running
timeFrame: 1 month
measure: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running
timeFrame: 1 month
Other outcomes:
measure: The Effects of Marathon Running on cardiac biomarkers
timeFrame: one months
Locations:
city: Munich
country: Germany
facility: Department of Preventive and Rehabilitative Sports Medicine
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar der TUM
name: Johannes Scherr, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.