NCT07058974

A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smokers
• Former Smokers

Interventions

Type	Name	Description
DRUG	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.
DRUG	rapamycin	Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
BEHAVIORAL	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-07-10
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study