A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

Not Applicable

Not yet recruiting

• Conditions: Smokers; Former Smokers
• Interventions: Drug: lamivudine; Drug: rapamycin; Behavioral: Exercise Regimen; Dietary Supplement: Spermidine

• Registration Number: NCT07058974
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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 renal disease
• Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
• Patients may not have a known chronic viral infection such as HIV or active Hepatitis B or C, or a known history of genital HSV. Patients who have spontaneously or through treatment cleared hepatitis B or C are candidates for the trial. If Hepatitis B core ab is positive must document a negative PCR.
• Patients may not have class 3 or 4 heart failure, or have experienced a myocardial infarction or cerebrovascular event in the past 6 months
• Patients may not have uncontrolled diabetes mellitus
• Patients may not have a history of clinically significant interstitial lung disease (ILD).
• Patients may not have clinically significant active wound healing due to recent injury or surgery
• Patients may not have signs or symptoms of clinically significant acute infectious illness on screening laboratory testing or physical examination.
• Patients may not have evidence of active or latent tuberculosis
• Patients may not have nephrotic range proteinuria on screening labs
• Patients may not have received a live virus within one month of study initiation.
• Patients cannot have uncontrolled hypertension (persistent systolic >160; diastolic >100)
• Patients with an inherited primary immunodeficiency
• Patients may not have a history of, or current evidence of, clinically significant chronic liver disease
• Patients may not be receiving any chronic immunosuppressive therapy.
• Patients may not be receiving medications that could increase rapamycin blood concentrations, such as strong inhibitors and inducers of CYP3A4 and/or P-gp (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin; rifampin or rifabutin), bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
• Patients may not be receiving medications that could decrease rapamycin blood concentrations, such as: carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
• Patients may not be receiving medications known to cause angioedema with concomitant use of rapamycin, such as angiotensin-converting enzyme (ACE) inhibitors. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and spermidine administered in conjunction with lamivudine (RTi)	lamivudine	Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days.
Exercise and spermidine administered in conjunction with lamivudine (RTi)	Exercise Regimen	Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days.
Exercise and spermidine administered in conjunction with lamivudine (RTi)	Spermidine	Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days.
Exercise and spermidine administered in conjunction with rapamycin (mTORi)	rapamycin	Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days.
Exercise and spermidine administered in conjunction with rapamycin (mTORi)	Exercise Regimen	Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days.
Exercise and spermidine administered in conjunction with rapamycin (mTORi)	Spermidine	Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days.

Primary Outcome Measures

Name	Time	Method
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0	at 180 days	Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0. Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Any patient experiencing a Grade 3 or 4 adverse event must hold drug until toxicity returns to grade 0-1. The treating investigator may hold study drug for any duration if the patient is deemed to be experiencing a Grade 1-2 adverse event related to study drug.
Number of participants with ability to complete >80% of specified pharmacological intervention	at 180 days	Feasibility of the trial is determined by participant documentation of taking at least 80% of the provided study drug on a regular basis, ability to complete \>80% of specified pharmacological intervention.

Secondary Outcome Measures

Name	Time	Method
Neutrophil to lymphocyte ratio (NLR)	at 180 days	Measure NLR from complete blood count.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States