Trials / Recruiting
RecruitingNCT05802121
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Western University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Hyperlipidemias
- Diabetes
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-07-02
- Primary completion
- 2026-09-01
- Completion
- 2027-06-01
- First posted
- 2023-04-06
- Last updated
- 2025-08-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05802121. Inclusion in this directory is not an endorsement.