Recruiting
Early Phase 1

Oral Acetate

Sponsor:

Western University

Code:

NCT05802121

Conditions

Prostate Cancer

Metabolic Syndrome

Obesity

Cardiovascular Morbidity

Bone Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apple Cider Vinegar

Study Details

Brief summary:

The overriding objectives of this study are:

1. Primary outcomes:

1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to a standard of care arm.
2. To confirm tolerability and assess for side effects of oral acetate supplementation.
2. Secondary outcomes:

1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

Conditions

Prostate Cancer

Metabolic Syndrome

Obesity

Cardiovascular Morbidity

Bone Diseases

Study ID

NCT05802121

Start date

Jul 2, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

For inclusion in this study, patients must fulfill all of the following criteria:

1. Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).
2. Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan

Patients fulfilling any of the following criteria are NOT eligible for participation in this study:

1. Age less than 18
2. Primary neuroendocrine prostate cancer
3. Treatment with ADT within the year leading up to enrolment
4. Planned or concurrent use of chromium supplementation for the study duration
5. Planned or concurrent use of apple cider vinegar supplementation for the study duration
6. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
7. Inadequate liver function (>2x upper limit of normal)
8. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
9. Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Apple Cider Vinegar

Jamison apple cider vinegar caplets (NPN: 80078433). Each patient will be instructed to take 1 acetate caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months.

no intervention: Observation

Observation group will follow standard of care treatment.

Interventions

Apple Cider Vinegar

Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433)

https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o

Primary outcome measure

  • Fecal Akkermansia muciniphilia counts [ Time Frame: 1 week ]
  • Fecal Akkermansia muciniphilia counts [ Time Frame: 1 month ]
  • Fecal Akkermansia muciniphilia counts [ Time Frame: 3 month ]
  • Fecal Akkermansia muciniphilia counts [ Time Frame: 4 month ]
  • Fecal Akkermansia muciniphilia counts [ Time Frame: 6 month ]
  • Side effects and tolerability [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A5W9

More Information

Sponsor

Western University

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • prostate cancer
  • metabolic syndrome
  • androgen deprivation therapy
  • microbiome
  • Akkermansias muciniphilia
  • cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University on 2025-08-20.