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

Cardiovascular Diseases Clinical Trial

— Enzy-MagIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916408
• Other study ID #: Enzy-MaGIC2013/1
• Secondary ID: 2013-001233-40
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2013
• Last updated: June 29, 2015
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Preventive and Rehabilitative Sports Medicine	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Effects of Marathon Running on cardiac biomarkers	Controlling for cardiac biomarker (Hs-Troponin T, Hs-CRP, BNP)after marathon	one months	No
Primary	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.	one months	No
Secondary	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	one months	No
Secondary	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)	1 month	No
Secondary	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)	1 month	No