Health TrialsbyHealthPanel

A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

ConditionsSmokersFormer Smokers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-80
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 65-80 years old

Current or former smokers

BMI 25-32

No cancer requiring active therapy within the last 2 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • lamivudine

    Drug

    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

    Drug

    Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.

  • Exercise Regimen

    Behavioral

    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

    Dietary supplement

    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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Exercise and spermidine administered in conjunction with lamivudine (RTi)Experimental treatment 3 interventions
Group B: Exercise and spermidine administered in conjunction with rapamycin (mTORi)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0

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.

Time frame
at 180 days
2

Number of participants with ability to complete >80% of specified pharmacological intervention

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.

Time frame
at 180 days

Secondary outcomes

1

Neutrophil to lymphocyte ratio (NLR)

Measure NLR from complete blood count.

Time frame
at 180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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