A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT07058974
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Former Smokers
- Smokers
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- lamivudine — DRUGLamivudine (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 — DRUGRapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
- Exercise Regimen — BEHAVIORALAll 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 — DIETARY_SUPPLEMENTSpermidine 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.
Study Details
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.
Key Dates
- Start date
- Aug 25, 2025
- Status verified
- Sep 2025
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 22 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Exercise and spermidine administered in conjunction with lamivudine (RTi)Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days.
- Experimental: Exercise and spermidine administered in conjunction with rapamycin (mTORi)Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days.
Primary Outcome Measure
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0 [ Time Frame: at 180 days ]
Central Contacts
- Thomas Marron, MD, PhD(212) 824-9472
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | Thomas Marron, MD, PhD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in New York, NY
By research site