InflammationPhase 1Enzy-MagICNCT01916408
The Effects of Enzymes and Flavonoids on Inflammation and Coagulation After Marathon
A Phase 1 study testing Wobenzym plus and PL 1 in people with Inflammation and Death, Sudden, Cardiac, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Death, Sudden, Cardiac, Death
- What is being tested?
- Wobenzym plus and PL 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Preventive and Rehabilitative Sports Medicine
Munich, Bavaria, 80992
About this study
Official title: The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
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.
Read the 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.
- Conditions
- Inflammation, Death, Sudden, Cardiac, Death, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
- Being tested
- Wobenzym plus, PL 1
- Keywords
- Exercise, Inflammation, Upper Respiratory Tract Illness, Oral Proteolytic and Hydrolytic Enzymes, Flavinoids
- Medical subject headings
- Inflammation, Death, Sudden, Cardiac, Death, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Death, Sudden, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wobenzym plusDrug
Also called manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/4
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 1Drug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PL 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one months
Secondary outcomes (3)
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
Measured: one months
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)
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Scherr, Dr. med., Principal investigator, Klinikum rechts der Isar der TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916408
- Sponsor's protocol ID
- Enzy-MaGIC2013/1
- Other IDs
- 2013-001233-40
- Acronym
- Enzy-MagIC
- Status last verified
- Jun 2015
- First submitted
- 15 May 2013
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29370708Grabs 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.
PubMed 26093876Grabs 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.
PubMed 24559067
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
- ClinicalTrials.gov ID
- NCT01916408
- Acronym / sponsor ID
- Enzy-MagIC / Enzy-MaGIC2013/1
- Conditions
- Inflammation, Death, Sudden, Cardiac, Death, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
- Keywords
- Exercise, Inflammation, Upper Respiratory Tract Illness, Oral Proteolytic and Hydrolytic Enzymes, Flavinoids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wobenzym plus | Active comparator | Drug: Wobenzym plus3 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. |
| Placebo PL1 | Placebo comparator | Drug: PL 13 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wobenzym plusAlso: manufacturing authorisation number DE_BE_01_MIA_2012_0034/5373/1 - MUCOS/43 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 |
| PL 1Also: Placebo3 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 | Placebo PL1 |
Primary outcome
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running
Time frame: one months
Change of the inflammatory marker (IL-6) before and after a marathon in relation to the consumption of oral hydrolytic enzymes and bioflavonoids.
3 secondary outcomes
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running
Time frame: one months
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running
Time frame: 1 month
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Derived from this study: PubMed 29370708Scherr 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.
- Derived from this study: PubMed 26093876Grabs 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.
- Derived from this study: PubMed 24559067Grabs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Scherr, Dr. med. principal investigator
Klinikum rechts der Isar der TUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wobenzym plus and PL 1 in people with Inflammation and Death, Sudden, Cardiac, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running (time frame: one months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916408, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.