BMC Sports Sci Med Rehabil. 2014 Feb 22;6(1):8. doi: 10.1186/2052-1847-6-8.
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 science, medicine & rehabilitation
Viola Grabs, David C Nieman, Bernhard Haller, Martin Halle, Johannes Scherr
Affiliations
Affiliations
- Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich, Germany. [email protected].
PMID: 24559067
PMCID: PMC3945524 DOI: 10.1186/2052-1847-6-8
Abstract
BACKGROUND: Regular moderate intensity physical activity positively influences the immune system with a lower incidence of upper respiratory tract infections (URTI) and lower levels of pro-inflammatory markers. However, marathon running due to its strenuous and prolonged nature results in immune perturbations with a major increase in pro-inflammatory markers and subsequent increased incidence of URTI. Furthermore, marathon running results in muscle damage and changes in hemostasis that promote a pro-thrombotic state.Naturally occurring hydrolytic enzymes and flavonoids have antioxidant, anti-inflammatory and fibrinolytic effects, and may serve as countermeasures to exercise-induced inflammation, immune dysfunction and URTI.The aim of this study is to determine whether the ingestion of oral hydrolytic enzymes and flavonoids before and after a marathon attenuates post-race muscle damage and inflammation, counters pro-thrombotic changes in hemostasis and decreases URTI incidence.
METHODS/DESIGN: The Enzy-MagIC-study (Enzymes, Marathon runninG, Inflammation, Coagulation) is a randomized, double-blind, placebo-controlled, monocenter phase I trial. 160 healthy males (age 20-65 years) will be randomized to receive either placebo or treatment (Wobenzym, MUCOS Pharma, Berlin, Germany) which contains the hydrolytic enzymes (bromelain, trypsin) and the flavonoid rutoside. One week before the marathon race, participants will begin daily ingestion of the investigational product (3×4 tablets). Intake will be continued for two weeks after the race (3×2 tablets per day). Clinical and laboratory measures will be collected 5-weeks and 1-week before the race, and immediately-, 24-h, 72-h, and 2 weeks after the race. The primary endpoint is the influence of the treatment on the pre-to-post marathon race plasma concentration change of the inflammatory marker interleukin-6 (IL-6). Secondary endpoints include the effect of treatment on salivary IgA concentration and the frequency of upper respiratory tract infections (URTI) for two weeks post-marathon as determined by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Furthermore, changes of muscular and rheological parameters will be measured before and after the marathon race.
DISCUSSION: We hypothesize that marathon-induced inflammatory perturbations and the incidence of subsequent URTI, muscular damage, and changes of hemostasis can be positively influenced by the anti-edematous, anti-inflammatory, antioxidant, and fibrinolytic effects of oral hydrolytic enzymes and flavonoids (Wobenzym).
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01916408.
References
- Crit Rev Oncog. 1997;8(1):47-69 - PubMed
- Med Sci Sports Exerc. 2012 Jan;44(1):18-26 - PubMed
- J Immunol. 2010 Jun 15;184(12):6815-21 - PubMed
- Mol Nutr Food Res. 2005 Mar;49(3):239-46 - PubMed
- Clin Exp Rheumatol. 2006 Jan-Feb;24(1):25-30 - PubMed
- J Physiol. 1999 Feb 15;515 ( Pt 1):287-91 - PubMed
- Pain. 1987 Aug;30(2):191-197 - PubMed
- Nephrol Dial Transplant. 1996 Jun;11(6):987-9 - PubMed
- Burns. 2001 Nov;27(7):709-16 - PubMed
- Cell Mol Life Sci. 2001 Aug;58(9):1234-45 - PubMed
- Am J Clin Pathol. 2002 Dec;118(6):856-63 - PubMed
- JAMA. 2001 Jul 18;286(3):327-34 - PubMed
- Arterioscler Thromb Vasc Biol. 2010 Oct;30(10):2047-52 - PubMed
- Free Radic Biol Med. 2006 Dec 15;41(12):1727-46 - PubMed
- Biochem J. 1990 Feb 1;265(3):621-36 - PubMed
- Scand J Med Sci Sports. 2006 Aug;16(4):287-93 - PubMed
- Clin Immunol. 2008 Mar;126(3):345-52 - PubMed
- Mol Nutr Food Res. 2007 Jun;51(6):684-91 - PubMed
- Am J Med. 2006 Nov;119(11):937-42 - PubMed
- Med Sci Sports Exerc. 2009 Jul;41(7):1467-75 - PubMed
- In Vivo. 1999 Jan-Feb;13(1):7-12 - PubMed
- In Vivo. 2005 Mar-Apr;19(2):417-21 - PubMed
- Am J Clin Nutr. 2002 Jul;76(1):93-9 - PubMed
- Clin Rheumatol. 2004 Oct;23(5):410-5 - PubMed
- Circulation. 2000 Apr 18;101(15):1767-72 - PubMed
- Eur J Appl Physiol. 2000 Dec;83(6):512-5 - PubMed
- Health Qual Life Outcomes. 2009 Aug 12;7:76 - PubMed
- Circ Res. 2002 Mar 8;90(4):465-72 - PubMed
- J Appl Physiol (1985). 2001 Jul;91(1):109-14 - PubMed
- Physiol Rev. 2008 Oct;88(4):1379-406 - PubMed
- J Athl Train. 1997 Oct;32(4):344-9 - PubMed
- Med Sci Sports Exerc. 2011 Oct;43(10):1819-27 - PubMed
- J Immunol. 2005 Sep 15;175(6):3463-8 - PubMed
- Clin Immunol. 2008 Jul;128(1):66-74 - PubMed
- Biochem Pharmacol. 1986 Jan 15;35(2):237-45 - PubMed
- FEBS Lett. 1997 Jun 2;409(1):12-6 - PubMed
- Med Sci Sports Exerc. 2007 Sep;39(9):1561-9 - PubMed
- Nutr Rev. 2008 Jun;66(6):310-20 - PubMed
- Arzneimittelforschung. 2000 Aug;50(8):728-38 - PubMed
- J Appl Physiol (1985). 2005 Apr;98(4):1154-62 - PubMed
- J Allergy Clin Immunol. 2004 Nov;114(5):997-1008; quiz 1009 - PubMed
- J Surg Res. 2006 Jun 15;133(2):150-8 - PubMed
- Br J Sports Med. 2003;37(5):433-5 - PubMed
- Thromb Haemost. 1996 Nov;76(5):738-42 - PubMed
- Adv Immunol. 1993;54:1-78 - PubMed
- Circulation. 2002 Mar 5;105(9):1135-43 - PubMed
- Mediators Inflamm. 2008;2008:109502 - PubMed
Publication Types