Evaluation of cardiocirculatory performance using clinical and relevant muscle laboratory parameters while taking Mg-Orotate and application of workouts
Conditions
Interventions
Trade Name: Magnerot® CLASSIC N
Product Name: Magnerot® CLASSIC N
Pharmaceutical Form: Tablet
INN or Proposed INN: MAGNESIUM OROTATE-DIHYDRATE
Other descriptive name: MAGNESIUM OROTATE-DIHYDRATE
Conce
Sponsors
Wörwag Pharma GmbH & Co. KG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Potential volunteer are obliged to be informed in details about the study and the loading results. In the study only included, who afterword signs a dated consent form. 2. Men between 18 and 35 years, which may have a regular workout. 3. No serious internal medical or neurological pre-existing diseases in the history (as judged by the investigator). 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chronic neurological or internal diseases. 2. Taking medications or food supplements and vitamins within the last 4 weeks. 3. Contraindications for the administration of magnesium orotate (e.g. allergy). 4. Contraindications for the application of local anesthetics (allergy, Hypersensitivity). 5. Participation in a drug trial within the last three months prior to study inclusion. 6. Clinically significant deviation of certain laboratory parameters (Hb <13 g / dl, Deviation of the liver values over twice the normal (ALT, AST, ALP), GFR <60 ml / min, serum electrolytes (Na, K, Mg) in the normal. PT / PTT value outside the normal. 7. Known coagulation disorders. 8. Taking drugs. 9. Venous conditions that do not allow multiple blood draws.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the proposed study the influence of a 4-week administration of MgOrotat (4500 mg / d) are examined for the training effect in healthy men. The effect of the medication is to be compared with the effect of (the standardized?) training. Finally, the interaction between workout and MgOrotat is examined, that is, whether the effect of MgOrotats and the training effect reinforce each other, inhibit or whether they act independently. To ensure the objectivity of performance or training success this are applied powerful physiological parameters of cardiopulmonary exercise testing and the lactate diagnostics. In addition, to be examined a potential effect of MgOrotat at the cellular level transfer based on muscle biopsies from the vastus muscle lateralis.;Secondary Objective: not applicable;Primary end point(s): ?VO2 max0-1: Change in VO2 max before and after training. ?P AT0-1: Change in performance on the cycle ergometer at the AT ;Timepoint(s) of evaluation of this end point: before and after training | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?LT0-1: Change in LT (lactate threshold) before training and after training ?Pmax0-1: Changing the maximum performance on the cycle ergometer before training and after training ?KP0-1: Change in the concentration of creatine phosphate and ATP in the muscle before training and after training ?ATP0-1: Change in the concentration of ATP (adenosine triphosphate) in the muscle before training and after training ?Gly0-1: Change in the concentration of glycogen in the muscle before training and after Training ;Timepoint(s) of evaluation of this end point: before and after training | — |
Countries
Germany
Contacts
Public ContactSponser Medical Responsible Person
Wörwag Pharma GmbH & Co. KG
Outcome results
None listed