What is apple cider vinegar studying for prostate cancer?

This trial is studying whether oral acetate from apple cider vinegar can increase a gut bacterium called Akkermansia muciniphila in men with metastatic prostate cancer. Researchers want to see if this change relates to improved metabolism and bone health. The study is sponsored by Western University and helps explore new ways to manage side effects of hormone therapy.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years or older with metastatic castration-sensitive prostate cancer who are planned to receive hormone therapy may be eligible. Participants must not have received recent hormone therapy or be currently taking apple cider vinegar or chromium supplements. Participants also need to be able to understand English or use an interpreter. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses vary by participant and may not be covered. Participants should consider their own travel and accommodation needs when joining the trial.

Actively Recruiting

Early Phase 1

Age: 18Years +

MALE

ID05802121

The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer

Led by Western University · Updated on 2025-08-20

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying men with metastatic castration-sensitive prostate cancer to see if taking oral acetate can increase the amount of a gut bacterium called Akkermansia muciniphila. The trial aims to confirm this increase compared to standard care and to assess how well patients tolerate oral acetate. The study also explores whether higher levels of this bacterium relate to better metabolic health and bone strength. This is an early phase 1 clinical trial sponsored by Western University. Participants are randomly assigned to one of two groups. One group takes an apple cider vinegar caplet daily, containing 143 mg with 36 acetic acid, for three months. The other group receives standard care without supplementation. The study includes follow-up periods lasting up to six months to monitor changes and side effects. Throughout the study, stool samples will be collected at multiple time points to measure Akkermansia muciniphila levels. Researchers will also evaluate various metabolic markers such as blood sugar, cholesterol, and insulin resistance, plus bone health indicators. Side effects and tolerability will be checked after three months. Participants are monitored over six months to assess both primary and secondary outcomes related to metabolism and bone health.

CONDITIONS

Brief Title

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Men aged 18 years or older
Histologically confirmed metastatic castration-sensitive prostate adenocarcinoma
Planned to receive androgen deprivation therapy (ADT)
Must have baseline imaging with CT abdomen and pelvis plus bone scan or PSMA PET scan

You will not qualify if you...

Age less than 18 years
Primary neuroendocrine prostate cancer
Treatment with ADT within the year before enrollment
Planned or current use of chromium supplements during study
Planned or current use of apple cider vinegar supplements during study
Unable to provide informed consent or understand/read English without interpreter
Liver function more than twice the upper limit of normal
Any condition or lifestyle factor posing significant risk or affecting study completion
Use of antibiotics that cannot be stopped and remain off during the trial

Research Team

Kaydee Connors

Stephen Mardell

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