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

T

Technical University of Munich

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: PL 1
Drug: Wobenzym plus

Study type

Interventional

Funder types

Other

Identifiers

NCT01916408
Enzy-MaGIC2013/1
2013-001233-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

Male

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups, including a placebo group

Wobenzym plus
Active Comparator group
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.
Treatment:
Drug: Wobenzym plus
Placebo PL1
Placebo Comparator group
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.
Treatment:
Drug: PL 1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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