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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04216004
Eligibility Criteria:
Inclusion Criteria:
* Obese (BMI, body mass index ≥30, \<40 kg•m-2)
* Age 40-59
* Pre-menopausal
* Sedentary/insufficiently active for prior 6 months (mo)
* Weight stable for prior 6 mo
Exclusion Criteria:
* Tobacco, nicotine (patch/gum) use (previous 6 mo)
* Alcohol consumption \>10 drinks per week
* Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
* Cardiovascular disease, arrhythmias
* Hypogonadism
* Asthma
* History of uncontrolled hypertension
* Orthopedic injury/surgery (within 1 yr)
* Hepatorenal, musculoskeletal, autoimmune, or neurological disease
* History of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
* Consumption of thyroid, androgenic, or other medications known to affect endocrine function
* Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
* Pregnancy
* Allergy to dairy product or lactose intolerance
* Fasting plasma glucose (FPG) ≥ 126 mg/dL
* Oral glucose tolerance test (OGTT) ≥ 200 mg/dL
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
59 Years
Study:
NCT04216004
Study Brief:
Protocol Section:
NCT04216004