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Akkermansia Muciniphilia and Metabolic Side Effects of ADT

NCT05802121 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Western University

    lead OTHER

Principal Investigators

  • Melissa Huynh, MD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2026-09-30
Completion
2027-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05802121 on ClinicalTrials.gov