Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial

Conditions
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Muscle Injury, Muscle Soreness, Exercise Induced Muscle Damage

Intervention / Treatment
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* Drug: Wobenzym® plus
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wobenzym® plus<br>Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day) | Drug: Wobenzym® plus<br> <br> |
| Placebo Comparator: Placebo equates Wobenzym® plus but without active ingredients<br>3x4 capsules/ day | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Multidimensional approach for recovery and acute phase after eccentric stress test. Will be assessed at different time points before and after an excentric stress test and the reduction of these parameters under treatment will be calculated. | immediately before, 24h post, 48h post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal concentric strength (Nm) before and after the stress test | Reduction of strength induced by the excentric stress test | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | 
| Pressure induced pain | Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | 
| Blood routine parameters | Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | 
| blood pressure | Blood pressure and heart rate as safety parameter | immediately before, 24h, 48h, 72h | 
| Movement induced pain | Pain induced by a standardised movement and rated by the volunteer via VAS. | immediately before, 0h, 3h, 6h, 24h, 48h, 72h post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Proteolytic enzymes, Muscle strength Dynamometer, Muscle soreness, Exercise induced muscle damage