A Phase 1b, Multi-cohort Clinical Trial Assessing Safety and Feasibility of Exercise and Spermidine Administered in Conjunction With Lamivudine (RTi) or Rapamycin (mTORi) to Assess Impact on Dynamic Changes of Inflammation and Aging
Icahn School of Medicine at Mount Sinai
Summary
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.
Eligibility
- Age range
- 65–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients 65-80 years old * Current or former smokers * BMI 25-32 * No cancer requiring active therapy within the last 2 years * No autoimmune disease requiring disease modifying agents * No patients with CKD stage 3/4 or ESRD * No class 3 or 4 heart failure Exclusion Criteria: * Patients may not have cancer requiring active therapy within the last 2 years * Patients may not have autoimmune disease requiring disease modifying agents * Patients may not be receiving immune modifying biologic therapies * Patients may not have chronic kidney disease stage 3/4 or end stage r…
Interventions
- Druglamivudine
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.
- Drugrapamycin
Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
- BehavioralExercise Regimen
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.
- Dietary SupplementSpermidine
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.
Location
- Mount Sinai HospitalNew York, New York