Exercise Induced Muscle Damage, Muscle Injury, Muscle Soreness
Conditions
Keywords
Muscle soreness, Exercise induced muscle damage, Inflammation, Proteolytic enzymes, Muscle strength Dynamometer
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.
Interventions
DRUGWobenzym® plus
OTHERPlacebo
Sponsors
Mucos Pharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | immediately before, 24h post, 48h post | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal concentric strength (Nm) before and after the stress test | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | Reduction of strength induced by the excentric stress test |
| Pressure induced pain | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | Pain induced by the stress test rated via Algometry kg/cm\*cm induced by standardised pressure |
| Blood routine parameters | immediately before, 0h, 3h, 6h, 24h, 48h, 72h | Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters |
| blood pressure | immediately before, 24h, 48h, 72h | Blood pressure and heart rate as safety parameter |
| Movement induced pain | immediately before, 0h, 3h, 6h, 24h, 48h, 72h post | Pain induced by a standardised movement and rated by the volunteer via VAS. |
Countries
Germany
Outcome results
None listed