RecruitingEARLY_PHASE1INTERVENTIONAL

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

This study is for men with prostate cancer who are starting hormone therapy, also known as ADT. Hormone therapy can sometimes lead to side effects like weight gain, diabetes, and bone problems. Researchers think that a type of healthy gut bacteria, called A. muciniphilia, might help with these issues. This study will give some participants apple cider vinegar to see if it increases these beneficial bacteria in their gut. The main goals are to check if this happens and if the apple cider vinegar is safe. They will also look at whether more of these bacteria lead to better overall health, such as healthier blood sugar levels and stronger bones.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

Western University

Enrolment target

Start

02 Jul 2025

Estimated completion

01 Jun 2027

Prostate Cancer Metabolic Syndrome Obesity Cardiovascular Morbidity Bone Diseases Hyperlipidemias Diabetes

What is this study about?

When men with prostate cancer receive hormone therapy (ADT), it's a very effective treatment, but it can sometimes cause unwanted side effects. These can include changes to your body's metabolism, such as gaining weight, developing high cholesterol, or even diabetes. It can also affect your bone health, making them weaker over time.

Researchers are interested in a specific type of 'good' gut bacteria called Akkermansia muciniphila. This bacteria is thought to play a helpful role in how our bodies manage sugar and fat, and could even influence bone health. There's some early evidence that substances like apple cider vinegar might encourage more of this beneficial bacteria to grow in your gut.

This study wants to find out if giving men apple cider vinegar while they are starting hormone therapy for prostate cancer can boost the levels of Akkermansia muciniphila in their gut. If it does, the researchers then want to explore whether having more of these bacteria can help lessen some of those common side effects of hormone therapy. This could potentially lead to better overall health and quality of life for patients.

Key takeaways

Study is for men with prostate cancer starting hormone therapy.
Investigating if apple cider vinegar boosts helpful gut bacteria.
Hoping to reduce side effects like weight gain and diabetes.
Will check safety and how well apple cider vinegar is tolerated.
Participation involves regular check-ups, blood, and stool samples.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer that has spread to other parts of the body (metastatic) and who are specifically starting hormone therapy for the first time or haven't had it in the last year. You would need to have had recent scans to show your cancer.

However, there are several reasons why you might not be able to join. For example, if you have a rare type of prostate cancer (neuroendocrine), or if you're already taking chromium supplements or apple cider vinegar. If you can't understand English and don't have an interpreter, or if you have serious liver problems, you wouldn't be able to participate. Also, if you need to take antibiotics continuously during the study, you might not be suitable.

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 18 or older?
Do you have prostate cancer that has spread, and are you about to start hormone therapy for it?
Are you generally healthy enough to take part in a study?
Are you able to avoid taking other apple cider vinegar or chromium supplements during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be asked to take apple cider vinegar (or perhaps a dummy treatment) by mouth. The study involves regular visits where doctors will check your general health, collect stool samples to measure the gut bacteria, and take blood samples to look at your metabolism and bone health. You will have regular appointments and medical tests throughout the study to monitor your progress and check for any side effects. The total duration of your participation in the study would be determined by the specific research plan, but generally, these types of studies involve several months of active involvement and follow-up.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a closer watch on your health and potentially helping to manage side effects from your prostate cancer treatment, although this is not guaranteed. However, there are also potential risks, including possible side effects from the apple cider vinegar (though it's generally considered safe). There's always a small chance of discomfort from blood tests or other procedures. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

London Health Sciences Centre - Victoria Hospital
Verified postcode
London, Canada· Recruiting

Common questions

What is hormone therapy (ADT)?

Hormone therapy is a common treatment for prostate cancer that aims to lower the levels of male hormones, which can help stop cancer cells from growing.

What are 'metabolic side effects'?

These are changes in how your body handles energy, sugar, and fat, and can include things like weight gain, high cholesterol, or developing diabetes.

What is Akkermansia muciniphila?

This is a type of beneficial bacteria that lives in your gut and is thought to play a positive role in your overall health, especially how your body uses sugar and fat.

Will I know if I'm getting apple cider vinegar or a dummy treatment?

This information is usually kept secret from participants and doctors during the study to ensure fair results. This is called 'blinding'.

Do I have to stop my current prostate cancer treatment?

No, this study is designed for men who are starting hormone therapy; it works alongside your existing standard care, not as a replacement.

How to find out more

Kaydee Connors

kaydee.connors@lhsc.on.ca 519-685-8500 Official trial record

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