Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Early Phase 1

Not yet recruiting

• Conditions: Prostate Cancer; Hyperlipidemias; Metabolic Syndrome; Obesity; Cardiovascular Morbidity; Bone Diseases; Diabetes
• Interventions: Drug: Apple Cider Vinegar

• Registration Number: NCT05802121
• Lead Sponsor: Western University

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 placebo.

2. To confirm tolerability and assess for side effects of delayed oral acetate supplementation.

2. Secondary outcomes:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apple Cider Vinegar	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.

Primary Outcome Measures

Name	Time	Method
Fecal Akkermansia muciniphilia counts	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	3 months	We will record side effects reported by the participants and the rate of Discontinuation of the intervention.

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters: fasting plasma glucose	6 months	Fasting plasma glucose (mmol/L)
Metabolic parameters: total cholesterol	6 months	Total cholesterol (mmol/L)
Metabolic parameters: PSA	3 months	PSA (ng/mL)
Metabolic parameters: hemoglobin	6 months	Hemoglobin (g/L)
Metabolic parameters: HbA1C	3 months	HbA1c (%)
Metabolic parameters: HbA1c	6 months	HbA1c (%)
Metabolic parameters: serum creatinine	3 months	Serum creatinine (µmol/L)
Metabolic parameters: serum calcium	6 months	Serum calcium (µmol/L)
Metabolic parameters: triglycerides	6 months	Triglycerides (mmol/L)
Metabolic parameters: LDL cholesterol	6 months	LDL cholesterol (mmol/L)
Metabolic parameters: HDL cholesterol	6 months	HDL cholesterol (mmol/L)
Metabolic parameters: alanine transferase	6 months	Alanine transferase (U/L)
Metabolic parameters: aspartate aminotransferase	6 months	Aspartate aminotransferase (U/L)
Metabolic parameters: Insulin resistance index (HOMA IR)	3 months	Insulin resistance index (HOMA IR)
Metabolic parameters: HOMA IR	6 months	Insulin resistance index (HOMA IR)
Bone health: dp-ucMGP levels	6 months	Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline
Bone health: Vitamin K2	6 months	Vitamin K2 levels