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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05460351
Eligibility Criteria:
Inclusion Criteria:
* Able to provide own transportation to study testing visits and intervention
* Able to read and write in English
* Nondiabetic, i.e. fasting glucose \< 126 mg/dl
* Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)
* Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.
Exclusion Criteria:
* Smoking or use of chewing tobacco
* Involved in another intervention research study
* Diabetic (type 1 or 2)
* Atrophic gastritis
* Hypo- or hyperthyroidism
* Gout or history of kidney stones
* History of hypotension
* Premenopausal (women)
* Aversion to study-related testing procedures
* Allergy/sensitivity/aversion to beetroot beverages or protein supplement
* Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement
* Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases)
* Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism
* Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons
* Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program
* Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05460351
Study Brief:
Protocol Section:
NCT05460351