RecruitingNAINTERVENTIONAL

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

As we get older, our muscles can naturally lose strength and size, even with exercise. This can make everyday activities harder. Scientists are exploring new ways to help maintain muscle health in older age. This study investigates the effects of a drug called Rapamune on aged muscles. Rapamune works by influencing a natural body process known as mTOR, which is important for muscle building, though too much activity in this pathway might be unhelpful as we age. Researchers want to see if Rapamune, either by itself or when combined with resistance exercise, can help older men keep their muscles strong. They will recruit healthy men over 50 to understand how this drug could potentially reduce muscle problems linked to ageing.

At a glance

Status

Recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

06 Aug 2021

Estimated completion

01 May 2027

Muscle Atrophy Age-Related Sarcopenia

What is this study about?

Imagine your muscles as important building blocks for your body. Not only do they help you move around, but they also play a vital role in keeping your whole body healthy, acting as a store of energy and nutrients. As we get older, it's common for muscles to become smaller and weaker, a condition known as muscle atrophy or sarcopenia. This can make daily tasks more challenging and increase the risk of falls or other health problems. Exercise, especially strength training, is usually the best way to keep muscles strong, but sometimes it's not enough, or older people find it hard to do.

Researchers are interested in a natural process in our bodies called mTOR. This process is like a signal that tells your muscles to grow and repair themselves, especially after you eat protein or exercise. While mTOR is good for building muscles, scientists are starting to think that in older age, too much mTOR activity might actually have some negative effects on muscle maintenance. They've seen in animal studies that medicines that block this mTOR pathway could potentially help with age-related health issues and improve overall well-being.

This study will look at how a drug called Rapamune, which blocks the mTOR pathway, affects the muscles of older men. The researchers want to understand if this drug can help counteract the natural muscle loss that happens with ageing, both on its own and when combined with a specific type of exercise. By studying Rapamune, they hope to find new ways to help older people maintain their muscle strength and independence for longer.

Key takeaways

This study aims to understand how a drug (Rapamune) affects age-related muscle loss.
It involves men aged 50-90, some of whom will also do resistance exercise.
Rapamune works by affecting a natural body process important for muscle growth.
The goal is to find new ways to help older people keep their muscles strong.
Participation involves taking tablets and having health assessments like MRI scans.
You can withdraw from the study at any time if you decide it's not for you.

Who may be eligible?

For this study, researchers are looking for around 16 healthy men who are aged 50 or over, up to 90 years old. An important part of being eligible is that you must be able to give your full agreement to take part and understand what the study involves. You also need to be fit enough to do the resistance exercise training that is part of the study.

However, there are certain reasons why you might not be able to join. These include if your body mass index (BMI) is very low (under 18) or very high (over 35), or if you have certain existing health conditions. For example, if you have severe heart, lung, or metabolic diseases like uncontrolled high blood pressure or diabetes, or if you've had a recent stroke, you wouldn't be able to participate.

Other reasons for not being able to join include if you have problems with blood clotting, certain nerve or muscle conditions like epilepsy, or if you've taken part in another research study involving invasive procedures in the last three months. You also can't participate if you have something that would prevent you from having an MRI scan (like a pacemaker or certain metal implants), or if there are reasons you shouldn't take Rapamune, such as if you are due for certain vaccinations.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged between 50 and 90?
Are you generally healthy and able to exercise?
Do you have a healthy weight (BMI between 18 and 35)?
Have you avoided other research studies with invasive procedures in the last 3 months?
Do you have no major heart, lung, or metabolic health conditions?
Are you able to have an MRI scan (e.g., no pacemaker or certain metal implants)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to visit the research centre a few times over a period of time that will be explained to you. During these visits, you will undergo various assessments to understand your muscle health, such as MRI scans to measure muscle size and strength tests. You will also be given the study drug, Rapamune, in tablet form, or a placebo (a dummy pill), depending on what group you are in. Some participants will also take part in a supervised resistance exercise training programme for one of your legs. This will involve using exercise equipment. Researchers will monitor your health throughout the study. The total duration of your involvement will be clearly explained before you agree to participate.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to scientific understanding of muscle ageing, and it's possible you might see some improvements in your muscle strength. However, there's no guarantee of direct personal benefit. As with any medication, Rapamune may have side effects, and these will be fully explained to you before you agree to take part. There may also be some discomfort from the exercise or assessments like MRI scans. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Nottingham School of Medicine
Verified postcode
Derby, United Kingdom· Recruiting

Common questions

What is mTOR and why is it important?

mTOR is a signal in your body that helps your muscles grow and repair. Scientists are looking into how its activity might change with age and affect muscle health.

What is Rapamune?

Rapamune is a drug that works by blocking the mTOR pathway. This study is testing if it can help older men maintain muscle strength.

Will I have to do exercise in this study?

Some participants will be asked to do resistance exercise training for one leg, alongside taking the study drug or a placebo.

What is a placebo?

A placebo is a 'dummy' tablet that looks like the study drug but contains no active medicine. It helps researchers compare the true effects of the real drug.

Is this study only for men?

Yes, this particular study is recruiting healthy male volunteers aged 50 to 90 years old.

How to find out more

Philip Atherton, PhD

philip.atherton@nottingham.ac.uk 01332724725 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.