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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT02261961
Eligibility Criteria:
Inclusion Criteria:
* Veteran
* Age 60-80 years
* Body Mass Index of 18.5 - 29.9 kg/m2
Exclusion Criteria:
* Currently participating in any other research study involving an intervention
* Smokes tobacco products
* Tetanus or TDAP vaccine in previous two years
* Allergic to vaccination
* Seizure in past 3 months
* Guillain-Barre Syndrome in past 3 months
* Takes the medications heparin, plavix / clopidogrel, or coumadin / warfarin
* Allergic to lidocaine
* Significant problem with fainting
* Problems walking or exercising with both legs
* Participated in a weight-lifting program targeting the thighs in last 3 months
* Pains, tightness or pressure in chest during physical activity
* Metastatic cancer or undergoing chemotherapy
* Cerebral aneurysm or intracranial bleed in past year
* End-stage congestive heart failure (NYHA Stage IV)
* Unstable abdominal or thoracic aortic aneurysm (\>4cm)
* Renal disease requiring dialysis
* Allergic to vaccination
* Acute retinal hemorrhage or ophthalmologic surgery in past 3 months
* Bone fractures in the pelvis, legs, or feet in the last 3 months
* Hernia that causes pain during physical activity
* Myocardial infarction or cardiac surgery in past 3 months
* Pulmonary embolism or deep venous thrombosis in past 3 months
* Proliferative diabetic retinopathy or severe nonproliferative retinopathy
* Active suicidality or suicidal ideation
* Systemic bacterial infection
* Taking aspirin in any form and unable/unwilling to discontinue at least 10 days prior to muscle biopsy
* Unwilling to halt concurrent use of amino acid or protein supplements
* Unwilling to halt new use of nutritional supplements
* Unwilling to maintain current normal diet
* Encephalopathy in past 7 days
* Active oral or genital herpes
* Current use of appetite stimulants
* Current treatment for mania or bipolar disorder or taking lithium.
* Diagnosis of a significant cognitive deficit
* Untreated severe aortic stenosis
* Uncontrolled diabetes mellitus (HbA1C\>10)
* Uncontrolled hypertension or hypotension (\>160/100, \<100 systolic)
* Uncontrolled malignant cardiac arrhythmia
* Unstable angina
* Allergic to latex or tape
* Bleeding or clotting disorders
* Taking any non-ASA NSAID and unable or unwilling to discontinue use for 3 days prior to muscle biopsy
* Taking Fish Oil, Gingko, Garlic, Saw Palmetto, Turmeric, or Vitamin E and unable or unwilling to discontinue use for 10 days prior to the muscle biopsy procedure
* Significant problems with chronic pain
* Uncontrolled asthma or allergies
* Taking lactulose, nitrates plus hypertension medications or Viagra
* Liver cirrhosis or other severe liver disease
* History of peripheral artery disease
* Certain Steroid or androgen use in past 3 months
* Other physician judgment
* Significantly abnormal complete blood count (CBC) or prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT02261961
Study Brief:
Protocol Section:
NCT02261961