Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT01845558
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01845558
Study Brief:
Protocol Section:
NCT01845558