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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT04131712
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18-30 years of age.
* All races and ethnic backgrounds.
* Non-smoker and generally healthy.
Exclusion Criteria:
* Have a current lower extremity musculoskeletal injury or compromised musculoskeletal function that would not allow the safe use of crutches or a brace.
* Previous lower extremity surgeries or injury.
* Activities of daily living require long periods of standing or driving a manual transmission car.
* Body mass index (BMI) under 27.
* Evidence or signs and symptoms of metabolic syndrome or disorder (diagnosis of diabetes or insulin resistance, elevated BP, high fasting blood sugar, abnormal cholesterol or triglyceride levels).
* Thyroid disorder.
* Acute or chronic infections.
* Use of systemic steroids, anabolic steroids, or growth hormone.
* Chronic aspirin or NSAID use (unless it can be safely stopped prior to the biopsies), and any other use of an anticoagulant (e.g., Coumadin) or history of bleeding including history of hypo- or hyper-coagulation disorders.
* Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
* Any other condition or events considered exclusionary by the PI and/or physician, such as non-compliance.
* Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04131712
Study Brief:
Protocol Section:
NCT04131712