CompletedPhase IIInterventional

Assessment of the effect of geroprotectors on how cells work in the human body

As we grow older, changes inside our cells can lead to weakness and memory problems. Scientists have found substances called 'geroprotectors' that keep cells healthier in animals, and they now want to test them in people. This study is testing three safe options: a widely used diabetes drug called metformin, and two dietary supplements called fisetin and spermidine. Researchers want to find out if these can help protect human cells from the wear and tear of ageing. The study is based at the Queen Elizabeth Hospital in Birmingham and is looking for healthy volunteers aged 70 and older. Participants will take one of the study treatments and have simple health checks, including walking tests, memory questions, blood tests, and scans. Taking part helps researchers understand how we might help people stay active, sharp, and independent for longer in later life.

At a glance

Status

Completed

Phase

Phase II

Sponsor

University of Birmingham

Enrolment target

Start

01 Nov 2024

Estimated completion

01 May 2026

Ageing

What is this study about?

As we get older, our bodies change. While many people enjoy good health well into their later years, others develop problems like muscle weakness, frailty, or memory loss. Scientists believe these changes start deep inside our cells. In laboratory studies, certain substances called 'geroprotectors' helped cells repair themselves, allowing animals to live longer, healthier lives. Researchers now want to see if these same treatments can protect human cells.

This trial is looking at three different treatments. One is metformin, a well-known tablet normally used to treat type 2 diabetes. The other two are fisetin and spermidine, which are natural food supplements. While metformin is already proven to be safe for diabetes, using it to target the ageing process is new and currently considered 'off-label' in the UK. All three treatments have been carefully chosen because they are considered safe for older adults.

The main goal is to find out how these treatments affect muscles, brain function, and overall metabolism. By testing them in healthy older adults, doctors hope to gather the vital evidence needed to design larger studies. In the future, this work could help create new ways to prevent age-related illnesses and help people enjoy more years in good health.

Key takeaways

Tests three treatments to see if they can protect cells from the effects of ageing.
Open to healthy volunteers aged 70 and over who live near Birmingham.
Compares a common diabetes tablet (metformin) with two natural food supplements.
Involves fitness tests, scans, blood tests, and a small fat tissue sample.
Aims to discover new ways to help people live longer, healthier, and more independent lives.

Who may be eligible?

This trial is open to healthy men and women aged 70 and older who can travel to the Queen Elizabeth Hospital in Birmingham. You must be able to understand and read English, and be happy to keep your usual diet and exercise routines during the study.

To keep everyone safe and ensure clear results, some people cannot take part. You cannot join if you currently smoke, have stopped smoking in the past year, or use nicotine products. You also cannot take part if you have diabetes, active cancer, untreated thyroid issues, or low vitamin B12 levels.

People taking certain medicines are also excluded. This includes strong blood thinners (low-dose aspirin is usually fine), anti-inflammatory painkillers, or drugs that affect the immune system. You will also not be able to join if you have significant kidney or liver problems, recent serious infections, or major surgery within the last two months.

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.

I am aged 70 or older.
I do not smoke and have not used nicotine products in the last 12 months.
I do not have diabetes or active cancer.
I am not taking strong blood-thinning medicines (such as warfarin).
I am able to travel to the Queen Elizabeth Hospital in Birmingham for visits.
I can read, write, and understand English comfortably.

Answer every question to see your result.

What does participation involve?

If you take part, you will be given one of the three study treatments: metformin, fisetin, or spermidine. You will take the treatment as instructed by the team and visit the hospital clinic in Birmingham for regular check-ups.

During your visits, researchers will check your fitness through simple tasks. These include a grip strength test, a short four-metre walk, and standing up from a chair. You will also answer questionnaires about your memory, mood, and day-to-day life, and wear a special cap for a painless brainwave test.

The team will take ultrasound scans of your thigh muscles and measure your body fat and muscle levels. You will need to provide blood samples (up to five tablespoons at a time) and collect stool (poo) samples at home using a kit. A doctor will also take a tiny sample of fat tissue from under your skin using a local anaesthetic to numb the area. The study runs over several visits, and the research team will support you at every stage.

Potential risks and benefits

You may not get any direct health benefit from taking part, but you will be playing an important role in research that could help future generations stay healthier for longer. There are some risks to consider. Some walking and balance tests may feel tiring, though staff will always be right there to prevent falls. Blood tests and fat samples can cause brief pain, bruising, or light-headedness. Metformin can cause mild tummy upset or nausea, though starting on a low dose helps prevent this, and you can stop the medication at any time if you feel unwell. You are free to withdraw from the trial whenever you wish without giving a reason.

Locations (1)

Queen Elizabeth Hospital Birmingham
Approximate
Birmingham, England

Common questions

What is a 'geroprotector'?

A geroprotector is any medicine or supplement that aims to slow down the biological ageing process by helping cells repair themselves and stay healthy.

What does taking metformin 'off-label' mean?

It means the drug is approved and licensed in the UK for diabetes, but it is being tested here for a different purpose that is not yet officially approved.

Are the supplements safe?

Yes, fisetin and spermidine are natural dietary supplements with very good safety records, and no significant side effects are expected from taking them.

Will taking part cost me anything?

No, you do not pay for any study medicines or tests. The study team can tell you if help is available with your travel expenses.

Can I leave the study if I change my mind?

Yes, taking part is entirely voluntary. You can choose to stop at any point, and your standard medical care will not be affected in any way.

How to find out more

Daisy Wilson

d.v.wilson@bham.ac.uk +44 (0)121 3713264 Official trial record

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