The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Western University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Fecal Akkermansia muciniphilia counts
Study Overview
Brief Summary
The overriding objectives of this study are:
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Primary outcomes:
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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.
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To confirm tolerability and assess for side effects of oral acetate supplementation.
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Secondary outcomes:
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To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Apple Cider Vinegar (Drug)
Outcomes
Primary Outcomes
Fecal Akkermansia muciniphilia counts
Time Frame: 6 month
Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.
Side effects and tolerability
Time Frame: 3 months
We will record side effects reported by the participants and the rate of Discontinuation of the intervention.
Secondary Outcomes
- Metabolic parameters: fasting plasma glucose(6 months)
- Metabolic parameters: total cholesterol(6 months)
- Metabolic parameters: PSA(3 months)
- Metabolic parameters: hemoglobin(6 months)
- Metabolic parameters: HbA1C(3 months)
- Metabolic parameters: HbA1c(6 months)
- Metabolic parameters: triglycerides(6 months)
- Metabolic parameters: LDL cholesterol(6 months)
- Metabolic parameters: HDL cholesterol(6 months)
- Metabolic parameters: serum creatinine(3 months)
- Metabolic parameters: serum calcium(6 months)
- Metabolic parameters: alanine transferase(6 months)
- Metabolic parameters: aspartate aminotransferase(6 months)
- Metabolic parameters: Insulin resistance index (HOMA IR)(3 months)
- Metabolic parameters: HOMA IR(6 months)
- Bone health: dp-ucMGP levels(6 months)
- Bone health: Vitamin K2(6 months)
Investigators
Melissa Huynh
Assistant Professor
Western University