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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT04080102
Eligibility Criteria:
Inclusion Criteria:
* Men and women (25-50 years).
* Overweight and obese: body mass index (BMI) of 27 - 40 kg·m-2 and/or percent body fat \> 25% for men, and BMI of 25 - 40 kg·m-2 and/or Percent Body Fat \> 30% for women.
* Healthy, non-smokers.
* Women: eumenorrheic, reporting consistent menstruation, having 3 regular cycles in the 3 months prior to enrollment, and not pregnant or planning on becoming pregnant.
Exclusion Criteria:
* Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation.
* Have uncontrolled hypertension or an abnormal electrocardiogram.
* Have a diagnosed mental disorder
* Inconsistently taking medications or taking medications that may influence study outcomes.
* Participating in more than 150 minutes per week of moderate exercise, more than 2 days per week of resistance training, or currently participating in high intensity interval training or participated in HIIT within the previous 12 weeks.
* Lost or gained greater than eight pounds within three months prior to the enrollment.
* Currently consuming a high protein diet (,1.6 g·kg-1·day-1 and \<25% of calories from protein).
* Currently consuming meal replacements or dietary supplements that may taurine, or beta-hydroxy beta-methylbutyrate) within eight weeks prior to the enrollment date.
* Reports any known sensitivity to the Essential Amino Acid treatment.
* Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results.
* Has severely impaired hearing or speech or inability to speak English.
* Unwilling or unable to comply with the study protocol, including abstaining from, caffeine, tobacco, alcohol, and physical activity before testing days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT04080102
Study Brief:
Protocol Section:
NCT04080102