"Healthy volunteers" Influence of the product on exercise induced muscle damage, noticable in temporal strength loss and muscle soreness. The indication is as defined in the SmPC: Swelling and inflammtion caused by injuries/ Trauma. in this case injury of the muscle.
Conditions
Interventions
Trade Name: Wobenzym® plus
Product Name: Wobenzym® plus
Pharmaceutical Form: Coated tablet
CAS Number: 9001-00-7
Other descriptive name: BROMELAINS
Concentration unit: mg milligram(s)
Concentration
Sponsors
MUCOS Pharma GmbH & Co. KG
Eligibility
Sex/Gender
Male
Inclusion 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, 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: 35-45 years • BMI =20 kg/m2 and = 32 kg/m2 • medium concentric strength ability (180-300 Nm) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 musculo-skeletal 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 •Drug, alcohol and 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the current study is to investigate the therapeutic effect 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. As primary objective, the reduction of maximal isokinetic strength after exercise in the stronger leg and subjective pain after exercise are assumed to be the most promising parameters. Therefore these parameters are combined in a multidimensional approach summarizing different parameters and points of time to strengthen the power. The period after the stress test will be separately calculated for the acute phase (3h, 6h) and the recovery phase (24h-48h). ;Secondary Objective: The 0h (immideately post) 72h (long term) will be analyzed exploratory. Secondary objectives are the difference in delayed onset muscle soreness (DOMS) by using a visual analogue scale and the retrospective pain scale (Likert Scale). In addition, the difference of sensitivity against pressure will be analysed before and after exercise. Different biomarkers giving information about inflammatory response, metabolic fatigue, immunological response and anti-oxidative potential will be assessed at different points of time, too. Additionally, a global assessment of the effects of the study preparation at the end will be evaluated as secondary objective. ;Primary end point(s): The ensemble of appropriate single efficacy criteria shall be tested by a multivariate, directional test approach, reflecting the “global status after eccentric exercise” at different points in time: Recovery Phase: •Reduction of maximal isokinetic strength after stress test at 24h, 48h •Movement induced pain (VAS after performing a deep lunge of 90° for both legs) at 24h and 48h •Pressure induced pain: Nm/cm2 measured with algometry (in the middle of the muscle belly, m. rectus femoris) at 24h, 48h. Acute Phase: •Reduction of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Primary leg (maximum initial strength at baseline): primary efficacy criteria at 0h (immediately post exercise) and 72h (longterm effect) •Retrospective pain: Likert scale at 24h, 48h, 72h •Inflammatory response oIL-6 (pre, 0h, 3h, 24h post) oProstaglandin E metabolite derived from Cyclooxygenase 2 (pre, 0h, 3h, 6h, 24h post) •Metabolic marker oCreatin kinase (all time-points) oLDL (all time-points) oLactate (pre, 10 min and 30 min post ) •Redox-status oTOS (pre, 3h, 6h, 24h) oTAS (pre, 3h, 6h, 24h) •Immunological response oNK-cell-test (pre, 3h, 24h) ;Timepoint(s) of evaluation of this end point: Immediately before eccentric exercise (day 4 and 32) - pre Immediately after eccentric exercise (day 4 and 32) - 0h 3 hours after eccentric exercise (day 4 and 32) - 3h 6 hours after eccentric exercise (day 4 and 32) - 6h 24 hours after eccentric exercise (day 5 and 33) - 24h 48 hours after eccentric exercise (day 6 and 34) - 48h 72 hours after eccentric exercise (day 7 and 35) - 72h | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
BioTeSys GmbH
Outcome results
None listed