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

NCT01916408 | Completed Phase 1 DMC

• 2 other identifiers: Enzy-MaGIC2013/12013-001233-40
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running

  one months

• The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running

  1 month

• The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running

  1 month

Other Outcomes (1)

• The Effects of Marathon Running on cardiac biomarkers

  one months

Study Arms (2)

Wobenzym plus

ACTIVE COMPARATOR

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

Placebo PL1

PLACEBO COMPARATOR

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

Interventions

Wobenzym plus DRUG

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.

Also known as: manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4

Wobenzym plus

PL 1 DRUG

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.

Also known as: Placebo

Placebo PL1

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Preventive and Rehabilitative Sports Medicine

Munich, Bavaria, 80992, Germany

Location

Related Publications (3)

• 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.

  PMID: 29370708 DERIVED

• 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.

  PMID: 26093876 DERIVED

• 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.

  PMID: 24559067 DERIVED

MeSH Terms

Conditions

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

Interventions

Wobenzym

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Heart Arrest; Hematologic Diseases; Hemic and Lymphatic Diseases; Infections; Respiratory Tract Diseases; Behavior

Study Officials

• Johannes Scherr, Dr. med.

  Klinikum rechts der Isar der TUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: August 5, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

DE (1)