Exercise + Supplements for Reducing Signs of Aging

Overseen By Thomas Marron, MD, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, ACE inhibitors, Immunosuppressants

Disqualifiers: Cancer, Autoimmune disease, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a combination of exercise, spermidine supplements, and either rapamycin (a drug with potential anti-aging properties) or lamivudine (an antiviral medication) to determine their effect on slowing aging signs. The goal is to test the feasibility of combining these treatments. Participants will be divided into two groups: one will try the exercise and supplement combo with rapamycin, and the other with lamivudine, for 180 days. Suitable candidates are those aged 65-80, with a BMI between 25-32, who are current or former smokers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if you join this trial, especially if you are assigned to the rapamycin group. Medications that affect rapamycin levels or cause side effects with it, like some antibiotics and ACE inhibitors, cannot be used during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research has shown that rapamycin may reduce signs of aging. Tested in older adults, it was generally well-tolerated, with some experiencing mild side effects like tiredness. The FDA has approved lamivudine, typically used to treat HIV, indicating its safety, though its use for anti-aging is novel. Spermidine, found in foods, is considered safe and may promote healthy aging by enhancing cellular self-cleaning. Exercise, widely recommended for good health, has been shown to reduce inflammation. This trial is in its early stages, aiming to determine if this combination is safe and practical. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for reducing signs of aging because they combine exercise with spermidine and either rapamycin or lamivudine, offering a fresh approach to healthy aging. Unlike typical anti-aging treatments that focus on skincare or hormone replacement, these treatments work at the cellular level. Rapamycin targets mTOR pathways, which are crucial for cell growth and aging, while lamivudine acts on reverse transcription processes. Spermidine is linked to promoting cell renewal. This combination aims to not just slow aging but potentially rejuvenate cells, offering a comprehensive strategy for longevity.

What evidence suggests that this trial's treatments could be effective for reducing signs of aging?

Research has shown that exercise and spermidine can help slow aging. Spermidine supports the body's natural cleanup process, known as autophagy, which may help cells remain healthier longer. Exercise reduces age-related problems by lowering stress on the body. In this trial, one group of participants will follow an exercise regimen combined with spermidine and rapamycin, which affects a specific pathway in the body and has shown promise in reducing signs of skin aging and potentially aiding overall longevity. Another group will receive an exercise regimen combined with spermidine and lamivudine. While the role of lamivudine in anti-aging is less clear, it is under study for potential benefits. These treatments aim to address aging from multiple angles. ^{1 3 4 6 7}

Who Is on the Research Team?

Thomas Marron, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for current and former smokers interested in an anti-aging intervention. Specific eligibility details are not provided, but typically participants must meet certain health conditions to be included.

Inclusion Criteria

I am between 65 and 80 years old.

Current or former smokers

I haven't needed treatment for any cancer in the last 2 years.

Exclusion Criteria

I have a history of fatty liver disease related to metabolic issues.

I have not had severe heart failure or a heart attack/stroke in the last 6 months.

My blood pressure is not higher than 160/100.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform an exercise regimen and take spermidine with either rapamycin or lamivudine for 180 days

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Regimen
• Lamivudine
• Rapamycin
• Spermidine Supplementation

Trial Overview The study tests the effects of regular exercise combined with spermidine supplements and either rapamycin or lamivudine on systemic inflammation related to aging in smokers and ex-smokers.

How Is the Trial Designed?

Group I: Exercise and spermidine administered in conjunction with rapamycin (mTORi) Experimental Treatment 3 Interventions

Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days.

Group II: Exercise and spermidine administered in conjunction with lamivudine (RTi) Experimental Treatment 3 Interventions

Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07058974

A Study of Exercise and Pharmacologic Intervention on ... This is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6128428/

Spermidine delays aging in humans - PMC Spermidine may counteract the general clock of aging, by a global effect on cellular fitness (A), or may exert specific effects on multiple organ systems ...

3. cell.com cell.com/cell-metabolism/fulltext/S1550-4131(23)00458-8

Human trials exploring anti-aging medicines Thus, spermidine has the potential to promote healthy aging by ramping up autophagy, but the extent to which it will play a major role in ...

4. mdpi.com mdpi.com/1422-0067/26/15/7573

Which Approach to Choose to Counteract Musculoskeletal ... Physical exercise is a valuable tool in the prevention and treatment of age-related musculoskeletal disorders, as it is known to reduce oxidative stress, ...

5. mountsinai.org mountsinai.org/clinical-trials/search

Find a Clinical Trial | Mount Sinai - New York This is a study assessing the feasibility of performing an anti-aging ... exercise regimen, spermidine supplementation, and either rapamycin or lamivudine.

6. mountsinai.org mountsinai.org/clinical-trials/study-of-exercise-pharmacologic-intervention-on-systemic-inflammation

A Study of Exercise and Pharmacologic Intervention on ... Summary: This is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8110654/

Novel aspects of age-protection by spermidine ... Spermidine-mediated age protection was associated with decreased telomere attrition, arguing in favour of a novel cellular mechanism behind the anti-ageing ...