Clinical trial NCT01845558: Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
Official title: Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Injury
Muscle Soreness
Exercise Induced Muscle Damage
Keywords: Muscle soreness
Exercise induced muscle damage
Inflammation
Proteolytic enzymes
Muscle strength Dynamometer
Lead sponsor: Mucos Pharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 69
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
* Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
* Non smoker
* Men with strength training experience
* Age: 20-50 years
* BMI ≥20 kg/m2 and ≤ 32 kg/m2
* medium concentric strength ability (150-300 Nm)

Exclusion Criteria:

* Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture.
* No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial
* Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2.
* For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening
* Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance)
* Drug, alcohol and/or medication abuse
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
* Blood donation within 4 weeks prior to trial start (visit 1) or during trial.

Primary outcomes:
measure: Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test
timeFrame: immediately before, 24h post, 48h post
Secondary outcomes:
measure: Maximal concentric strength (Nm) before and after the stress test
timeFrame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
measure: Pressure induced pain
timeFrame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
measure: Blood routine parameters
timeFrame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
measure: blood pressure
timeFrame: immediately before, 24h, 48h, 72h
measure: Movement induced pain
timeFrame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h post
Other outcomes:
Locations:
city: Fürstenfeld Bruck
country: Germany
facility: Sportschule FFb Puch GmbH
Study officials:
affiliation: PWC GmbH
name: Helmut Pabst, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: