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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT04848792
Eligibility Criteria:
Inclusion Criteria:
* Men and women, 60 years and older
* Competent to independently give informed consent
* Successful completion of screening
* Maximal oxygen consumption below the 60th percentile based on gender:
* Women: ≤ 21.2 mL/kg/min
* Men: ≤ 30.5 mL/kg/min
Exclusion Criteria:
* Estrogen supplementation (in any form) within the previous 6 months
* Any medication that could affect outcome measures such as statins, blood pressure medications, or anti-depressives
* Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day) and/or any supplements known to target Nrf2 including resveratrol, Protandim, and sulforaphane
* Current smoker
* Body Mass Index (BMI) greater than 33 kg/m2 (Class I Obesity)
* Any chronic illness that could affect outcome measures, including diabetes, liver or renal disease, or cancer (other than skin cancer)
* History of a myocardial infarction within the last 6 months, clinically significant aortic stenosis, use of cardiac defibrillator, or uncontrolled angina
* Clinically significant arrhythmia on a resting EKG or significant EKG changes during the baseline VO2 max test
* Any other condition that would contraindicate maximal exercise testing, including elevated blood pressure at rest (systolic BP \>150 or diastolic BP \>90 mm Hg on at least 2 measurements, at least 10 minutes apart) or musculoskeletal problems
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04848792
Study Brief:
Protocol Section:
NCT04848792