This is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, and either rapamycin or lamivudine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Lamivudine (Epivir) is a drug used typically to treat HIV and Hepatitis B Virus (HBV). It has not been studied when given in combination with spermidine.
Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
All experimental groups will receive an exercise regimen combining high-intensity interval training (HIIT) (targeting aerobic fitness) and resistance training (targeting strength and skeletal muscle mass preservation). The HIIT exercise component will consist of 2 sessions per week totaling 20 minutes per session. The resistance training component will consist of 3 sessions per week totaling 40 minutes per session.
Mount Sinai Hospital
New York, New York, United States
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0. Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Any patient experiencing a Grade 3 or 4 adverse event must hold drug until toxicity returns to grade 0-1. The treating investigator may hold study drug for any duration if the patient is deemed to be experiencing a Grade 1-2 adverse event related to study drug.
Time frame: at 180 days
Number of participants with ability to complete >80% of specified pharmacological intervention
Feasibility of the trial is determined by participant documentation of taking at least 80% of the provided study drug on a regular basis, ability to complete \>80% of specified pharmacological intervention.
Time frame: at 180 days
Neutrophil to lymphocyte ratio (NLR)
Measure NLR from complete blood count.
Time frame: at 180 days
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Spermidine is a polyamine that forms naturally in plants, animals, and microorganisms as a byproduct of protein breakdown. Participants will take an oral dosage of 2mg/day for 180 days.