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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07419633
Eligibility Criteria:
Inclusion Criteria:
•. 65 years of age
* English or French speaking
* Females not of childbearing potential
* Willing to maintain current lifestyle and dietary habits, including level of physical activity, allowed medication/supplements habits for the duration of the study
Exclusion Criteria:
* Known cardiac diseases, known arterial fibrillation, hepatic diseases, immune diseases (e.g. Individuals with an acute infectious disease, autoimmune disease or are immune compromised), ulcers, asthma, gout, severe anemia, hay fever, nasal polyps.
* Chronic kidney disease \[estimated glomerular filtration rate (GFR) \< 35 mL/min\].
* Neurological injury/disorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, myopathy, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy).
* Neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
* History of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the Medical Research Council Dyspnea Scale.
* Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks before screening are not eligible.
* Underlying muscle diseases, including a history of or currently active myopathy (e.g., dermatomyositis, polymyositis, etc.) or muscular dystrophies.
* Confirmed rheumatoid arthritis, acquired immunodeficiency syndrome (AIDS), type 1 or type 2 diabetes mellitus.
* History of cancer in the last 6 months.
* Not on any medications including NHPs/living with medical conditions that would compromise the study outcome or the safety of the research participant.
* Known allergy to study medication or its components (non-medicinal ingredients).
* Allergy to aspirin/salicylate or if using other drugs containing acetylsalicylic acid or other salicylates and a history of ASA-sensitive asthma/bronchospasm
The following list of medications/NHPs will be excluded (and weaned as seen necessary by the study physician) prior to and during the study:
* Participants on newly initiated cholesterol-lowering medication will be excluded. Those on stable regimens for ≥3 months will be included and will be monitored for potential interactions as per the HMB monograph.
* Medications associated with muscle weakness or immune effects (i.e., oral glucocorticoids).
* Medications or supplements affecting skeletal muscle metabolism or weight including: Use of MAO-I's (monoamine oxidase inhibitors), additional consumption of 2-HOBA, Vitamin D or HMB, anabolic steroids, selective androgen receptor modulators (SARMs), corticosteroids, GLP-1s, or other weight loss medications).
* Excessive protein supplementation (i.e., \>2.0 g/kg/day).
* All participants must be on a stable dose of allowed supplements/medications for at least 3 months prior to enrollment. All concomitant therapies will be documented.
Non-pharmacological interventions that could influence study outcomes (e.g., pulmonary rehabilitation, structured exercise programs) will not be permitted.
Participants undergoing such therapies will be excluded. Any new interventions started during the study must be reported and if judged inappropriate, will result in withdrawal from the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07419633
Study Brief:
Protocol Section:
NCT07419633