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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT05686967
Eligibility Criteria:
Inclusion Criteria:
* resting blood pressure \<140/90 mmHg;
* fasted glucose \<126 mg/dL;
* sedentary/recreationally active (\<2 days/wk vigorous exercise);
* healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, CBC and circulating thyroid levels) and ECG at rest and during exercise;
* nonsmokers;
* no use of medications that might influence cardiovascular function (i.e., antihypertensive, lipid lowering medications, blood thinners);
* no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to enrollment and for the duration of the study;
* no use of HT for at least 6 months;
* body mass index \<40kg/m2.
Exclusion Criteria:
* Volunteers will be excluded from the study if they have contraindications to MitoQ or AE.
* acute liver disease, history of venous thromboembolic events, preexisting or active cardiac, renal or hepatic disease, history of stomach ulcer or bleeding or epilepsy or other seizure disorder;
* diabetes, active infection, disease that affects the nervous system,
* an abnormal resting ECG, angina and/or ECG evidence of acute myocardial ischemia during the exercise test (development of ST-segment depression of more than 0.3 mV that is either horizontal, down-sloping, or slowly upsloping -less than 1 mvolt/sec and lasts more than 0.08 sec; ST elevation; chest pain or discomfort), bundle branch blocks, A-V block greater than first degree, arrhythmias;
* chronic infections;
* thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
* orthopedic or other problems that would interfere with participation in the exercise program
The volunteers who choose to participate will do so with the understanding that they will be randomly assigned to study groups that involve either AE+PL (33% chance), No AE+MitoQ (33% chance) or AE+MitoQ (33% chance).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
120 Years
Study:
NCT05686967
Study Brief:
Protocol Section:
NCT05686967