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RECRUITING
NCT07058974
PHASE1

A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Mount Sinai Hospital

New York, New York, United States