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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT06822556
Eligibility Criteria:
Inclusion Criteria:
* Healthy male (as determined by the Health Screening Questionnaire)
* Adult (aged ≥18 and ≤40 years old)
* Recreationally-active (≥2 and ≤4 exercise sessions per week) and a VO2max of ≥ 35 mL/kg/min and ≤ 65 mL/kg/min as determined from the preliminary exercise test
* No known history of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
* Non-smoker
* Healthy body mass index (BMI; ≥18.5 and ≤24.9 kg/m2)
* Not using any dietary supplements, including antioxidant and nitrate-rich supplements, currently or in the past one month
* Not a heavy drinker (≤ 14 units of alcohol) on most weeks
* Not using medication that may affect study measures
* Not participating in other studies currently or in the past two months prior to the consenting session (visit 1) or having an intention to participate in other studies over the period of this study
Exclusion Criteria:
* Female
* Aged \<18 and \>40 years old
* Sedentary or highly trained with a respective V#O2max of \< 35 mL/kg/min and \> 65 mL/kg/min as determined from the preliminary exercise test
* History of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
* Smoker
* Unhealthy body mass index (BMI;\<18.5 and \>24.9 kg/m2)
* Using any dietary supplements, including antioxidant and nitrate-rich supplements, currently or in the past one month
* Heavy drinker (\> 14 units of alcohol) on most weeks
* Using medication that may affect study measures
* Participating in other studies currently or in the past two months prior to the consenting session (visit 1) or having an intention to participate in other studies over the period of this study
Participants will be excluded from the biopsy sub-set if they report any of the following:
* Allergy to Lidocaine or any of the ingredients. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin.
* Infection or swelling where the injection will be given
* Blood infections or disorders
* In severe shock
* Low blood pressure
* Disease of the brain or spinal cord
* Sudden frequent episodes of loss of consciousness
* Myasthenia gravis, a severe muscle weakness
* Heart problems
Furthermore, Lidocaine injection will NOT be used in cases of:
* Severely disturbed cardiac conduction
* Bradycardia
* ADAMS-STOKES syndrome
* Wolfe Parkinson White syndrome
* Sudden heart failure
* Hypersensitivity to amide-type local anaesthetics
* Suspicion of hereditary tendency to malignant hyperthermia
* Disorders of blood coagulation
* Infection of the region to be injected
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06822556
Study Brief:
Protocol Section:
NCT06822556