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Impacts of Mechanistic Target of Rapamycin (mTOR) Inhibition on Aged Human Muscle (Rapamune)

NCT05414292 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-10

No results posted yet for this study

Summary

As people age, muscle mass and function is lost and exercise training is an important way to reduce the effects of this and remain independent. However, not everyone can perform this exercise and the muscle responses to exercise are often reduced in older people. So far there has been no drug found to specifically treat or reduce this problem.

Muscle size depends on the balance of muscle protein breakdown and synthesis (building). This balance is regulated by multiple signals within the body, but a particular molecule - the mechanistic target of rapamycin (mTOR), is known to play an important role. For protein synthesis to build up the muscles, this pathway is needed to start the process when triggered by eating protein or exercise. Although this would suggest that mTOR activity is good, excessive levels of this signalling seem to have negative impacts on muscle maintenance with age.

In animal studies, blocking mTOR signalling has stopped the development of a number of age-related diseases and increased health-span. Drugs that block this pathway (e.g. Rapamune) reduce the stimulation of muscle protein synthesis, possibly through changing the immune system, but conversely have also been shown to increase muscle size and reduce markers of nerve supply loss. This means that drugs which block the mTOR pathway could, in older people, help to reduce the negative impacts of excessive mTOR signalling on muscle size and function.

The investigators aim to recruit 16 healthy male volunteers over 50 years old to investigate how the drug Rapamune (which blocks the mTOR pathway) affects aged human muscle both on its own and when combined with resistance exercise training.

Conditions

  • Muscle Atrophy
  • Age-Related Sarcopenia

Interventions

DRUG

Rapamune (sirolimus) 1Mg Tablet

Take Rapamune to see the effect on muscle structure and function during a 14 week unilateral resistance exercise training programme.

BEHAVIORAL

Unilateral resistance exercise training

Participants will complete unilateral leg extension resistance training 3 times per week for 14 weeks at 75% of their 1 repetition maximum

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414292 on ClinicalTrials.gov