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A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
65 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2025-08-25
Completion Date
2026-07-01
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
lamivudine
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
Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
Exercise 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.
Spermidine
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.
Locations (1)
Mount Sinai Hospital
New York, New York, United States