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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03250234
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 - 39 years
* Weight stable (±5 lbs) for at least 2 months prior to the start of the study
* Body mass index (BMI) between 18.5-30 kg/m2
* Recreationally active based on assessment of physical activity history 2-4 days per week aerobic and/or resistance exercise
* Refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product for 10 days before and at least 5 days AFTER each muscle biopsy. (\*Tylenol® or acetaminophen is ok to use if needed for discomfort)
* Refrain from the use of alcohol and nicotine for the duration of the study
* Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®, etc.)
* Supervisor approved leave status for federal civilian employees working within the US Army Natick Soldier Systems Center
Exclusion Criteria:
* Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
* Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
* Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
* Anemia (HCT \< 38) and Sickle Cell Anemia/Trait
* Abnormal prothrombin time (PT)/ partial thromboplastin time (PTT) test or problems with blood clotting
* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
* Musculoskeletal injuries that compromise the ability to exercise
* Blood donation within 8 weeks of beginning the study
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT03250234
Study Brief:
Protocol Section:
NCT03250234