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NCT Number: NCT05802121

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

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.

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Key information

Conditions

Prostate Cancer Body Weight Bone Diseases Cardiovascular Diseases Cardiovascular Morbidity Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A5W9, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).
  • 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:

  • Age less than 18
  • Primary neuroendocrine prostate cancer
  • Treatment with ADT within the year leading up to enrolment
  • Planned or concurrent use of chromium supplementation for the study duration
  • Planned or concurrent use of apple cider vinegar supplementation for the study duration
  • Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
  • Inadequate liver function (>2x upper limit of normal)
  • 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
  • Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

Treatment and study plan

Apple Cider Vinegar

Drug

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 outcomes

  1. Fecal Akkermansia muciniphilia counts

    Time frame: 1 week

    Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.

  2. Fecal Akkermansia muciniphilia counts

    Time frame: 1 month

    Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.

  3. Fecal Akkermansia muciniphilia counts

    Time frame: 3 month

    Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.

  4. Fecal Akkermansia muciniphilia counts

    Time frame: 4 month

    Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.

  5. 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.

  6. 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

  1. Metabolic parameters: fasting plasma glucose

    Time frame: 3 months

    Fasting plasma glucose (mmol/L)

  2. Metabolic parameters: fasting plasma glucose

    Time frame: 6 months

    Fasting plasma glucose (mmol/L)

  3. Metabolic parameters: HbA1C

    Time frame: 3 months

    HbA1c (%)

  4. Metabolic parameters: HbA1c

    Time frame: 6 months

    HbA1c (%)

  5. Metabolic parameters: triglycerides

    Time frame: 3 months

    Triglycerides (mmol/L)

  6. Metabolic parameters: triglycerides

    Time frame: 6 months

    Triglycerides (mmol/L)

  7. Metabolic parameters: LDL cholesterol

    Time frame: 3 months

    LDL cholesterol (mmol/L)

  8. Metabolic parameters: LDL cholesterol

    Time frame: 6 months

    LDL cholesterol (mmol/L)

  9. Metabolic parameters: HDL cholesterol

    Time frame: 3 months

    HDL cholesterol (mmol/L)

  10. Metabolic parameters: HDL cholesterol

    Time frame: 6 months

    HDL cholesterol (mmol/L)

  11. Metabolic parameters: total cholesterol

    Time frame: 3 months

    Total cholesterol (mmol/L)

  12. Metabolic parameters: total cholesterol

    Time frame: 6 months

    Total cholesterol (mmol/L)

  13. Metabolic parameters: PSA

    Time frame: 6 months

    PSA (ng/mL)

  14. Metabolic parameters: PSA

    Time frame: 3 months

    PSA (ng/mL)

  15. Metabolic parameters: hemoglobin

    Time frame: 3 months

    Hemoglobin (g/L)

  16. Metabolic parameters: hemoglobin

    Time frame: 6 months

    Hemoglobin (g/L)

  17. Metabolic parameters: serum creatinine

    Time frame: 3 months

    Serum creatinine (µmol/L)

  18. Metabolic parameters: serum calcium

    Time frame: 3 months

    Serum calcium (µmol/L)

  19. Metabolic parameters: serum calcium

    Time frame: 6 months

    Serum calcium (µmol/L)

  20. Metabolic parameters: alanine transferase

    Time frame: 3 months

    Alanine transferase (U/L)

  21. Metabolic parameters: alanine transferase

    Time frame: 6 months

    Alanine transferase (U/L)

  22. Metabolic parameters: aspartate aminotransferase

    Time frame: 3 months

    Aspartate aminotransferase (U/L)

  23. Metabolic parameters: aspartate aminotransferase

    Time frame: 6 months

    Aspartate aminotransferase (U/L)

  24. Metabolic parameters: Insulin resistance index (HOMA IR)

    Time frame: 3 months

    Insulin resistance index (HOMA IR)

  25. Metabolic parameters: HOMA IR

    Time frame: 6 months

    Insulin resistance index (HOMA IR)

  26. Bone health: dp-ucMGP levels

    Time frame: 3 months

    Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline

  27. Bone health: dp-ucMGP levels

    Time frame: 6 months

    Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline

  28. Bone health: Vitamin K2

    Time frame: 3 months

    Vitamin K2 levels

  29. Bone health: Vitamin K2

    Time frame: 6 months

    Vitamin K2 levels

Study contacts

Contact information is provided by the study sponsor or research team.

Kaydee Connors

CONTACT

[email protected]

519-685-8500 ext. 56366

Stephen Mardell

CONTACT

[email protected]

519-685-8500 ext. 58448

Sponsors and collaborators

Lead sponsor

Western University

Other

Registry information

Official study title

The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 6, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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