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RecruitingNCT05802121Updated Aug 20, 2025

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

An Early Phase 1 interventional study of Apple Cider Vinegar in Prostate Cancer, Metabolic Syndrome and Obesity, sponsored by Western University. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Western University · Early Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

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.
02

Conditions studied

  • Prostate Cancer
  • Metabolic Syndrome
  • Obesity
  • Cardiovascular Morbidity
  • Bone Diseases
  • Hyperlipidemias
  • Diabetes

Keywords

  • prostate cancer
  • metabolic syndrome
  • androgen deprivation therapy
  • microbiome
  • Akkermansias muciniphilia
  • cardiovascular disease
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Western University is the lead sponsor of 14 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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

  1. Men ≥18 years of age with -proven castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).
  2. 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:

  1. Age less than 18
  2. Primary neuroendocrine prostate cancer
  3. Treatment with ADT within the year leading up to enrolment
  4. Planned or concurrent use of chromium supplementation for the study duration
  5. Planned or concurrent use of apple cider vinegar supplementation for the study duration
  6. Unable to provide or unable to understand or read the English language (unless accompanied by an interpreter)
  7. Inadequate liver function (>2x )
  8. 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
  9. Use of antibiotics that cannot be discontinued for a and remain off them for the duration of the trial
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Apple Cider Vinegar

  • No intervention
    Observation

    Observation group will follow standard of care treatment.

Interventions

  • DrugApple 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

06

What researchers measure

Primary outcomes

  1. Fecal Akkermansia muciniphilia counts

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

    Time frame: 1 week

  2. Fecal Akkermansia muciniphilia counts

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

    Time frame: 1 month

  3. Fecal Akkermansia muciniphilia counts

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

    Time frame: 3 month

  4. Fecal Akkermansia muciniphilia counts

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

    Time frame: 4 month

  5. Fecal Akkermansia muciniphilia counts

    Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.

    Time frame: 6 month

  6. Side effects and tolerability

    We will record side effects reported by the participants and the rate of Discontinuation of the intervention.

    Time frame: 3 months

Secondary outcomes

  1. Metabolic parameters: fasting plasma glucose

    Fasting plasma glucose (mmol/L)

    Time frame: 3 months

  2. Metabolic parameters: fasting plasma glucose

    Fasting plasma glucose (mmol/L)

    Time frame: 6 months

  3. Metabolic parameters: HbA1C

    HbA1c (%)

    Time frame: 3 months

  4. Metabolic parameters: HbA1c

    HbA1c (%)

    Time frame: 6 months

  5. Metabolic parameters: triglycerides

    Triglycerides (mmol/L)

    Time frame: 3 months

  6. Metabolic parameters: triglycerides

    Triglycerides (mmol/L)

    Time frame: 6 months

  7. Metabolic parameters: LDL cholesterol

    LDL cholesterol (mmol/L)

    Time frame: 3 months

  8. Metabolic parameters: LDL cholesterol

    LDL cholesterol (mmol/L)

    Time frame: 6 months

  9. Metabolic parameters: HDL cholesterol

    HDL cholesterol (mmol/L)

    Time frame: 3 months

  10. Metabolic parameters: HDL cholesterol

    HDL cholesterol (mmol/L)

    Time frame: 6 months

  11. Metabolic parameters: total cholesterol

    Total cholesterol (mmol/L)

    Time frame: 3 months

  12. Metabolic parameters: total cholesterol

    Total cholesterol (mmol/L)

    Time frame: 6 months

  13. Metabolic parameters: PSA

    PSA (ng/mL)

    Time frame: 6 months

  14. Metabolic parameters: PSA

    PSA (ng/mL)

    Time frame: 3 months

  15. Metabolic parameters: hemoglobin

    Hemoglobin (g/L)

    Time frame: 3 months

  16. Metabolic parameters: hemoglobin

    Hemoglobin (g/L)

    Time frame: 6 months

  17. Metabolic parameters: serum creatinine

    Serum creatinine (µmol/L)

    Time frame: 3 months

  18. Metabolic parameters: serum calcium

    Serum calcium (µmol/L)

    Time frame: 3 months

  19. Metabolic parameters: serum calcium

    Serum calcium (µmol/L)

    Time frame: 6 months

  20. Metabolic parameters: alanine transferase

    Alanine transferase (U/L)

    Time frame: 3 months

  21. Metabolic parameters: alanine transferase

    Alanine transferase (U/L)

    Time frame: 6 months

  22. Metabolic parameters: aspartate aminotransferase

    Aspartate aminotransferase (U/L)

    Time frame: 3 months

  23. Metabolic parameters: aspartate aminotransferase

    Aspartate aminotransferase (U/L)

    Time frame: 6 months

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

    Insulin resistance index (HOMA IR)

    Time frame: 3 months

  25. Metabolic parameters: HOMA IR

    Insulin resistance index (HOMA IR)

    Time frame: 6 months

  26. Bone health: dp-ucMGP levels

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

    Time frame: 3 months

  27. Bone health: dp-ucMGP levels

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

    Time frame: 6 months

  28. Bone health: Vitamin K2

    Vitamin K2 levels

    Time frame: 3 months

  29. Bone health: Vitamin K2

    Vitamin K2 levels

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • McKay RR, Feng FY, Wang AY, Wallis CJD, Moses KA. Recent Advances in the Management of High-Risk Localized Prostate Cancer: Local Therapy, Systemic Therapy, and Biomarkers to Guide Treatment Decisions. Am Soc Clin Oncol Educ Book. 2020 May;40:1-12. doi: 10.1200/EDBK_279459. PubMed 32412803 ↗
  • Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299. PubMed 11836291 ↗
  • Timilshina N, Breunis H, Alibhai SM. Impact of androgen deprivation therapy on weight gain differs by age in men with nonmetastatic prostate cancer. J Urol. 2012 Dec;188(6):2183-8. doi: 10.1016/j.juro.2012.08.018. Epub 2012 Oct 18. PubMed 23083859 ↗
  • Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741. PubMed 16921050 ↗
  • Seible DM, Gu X, Hyatt AS, Beard CJ, Choueiri TK, Efstathiou JA, Miyamoto DT, Mitin T, Martin NE, Sweeney CJ, Trinh QD, Beckman JA, Basaria S, Nguyen PL. Weight gain on androgen deprivation therapy: which patients are at highest risk? Urology. 2014 Jun;83(6):1316-21. doi: 10.1016/j.urology.2014.02.006. Epub 2014 Apr 13. PubMed 24726149 ↗
  • Sturgeon KM, Deng L, Bluethmann SM, Zhou S, Trifiletti DM, Jiang C, Kelly SP, Zaorsky NG. A population-based study of cardiovascular disease mortality risk in US cancer patients. Eur Heart J. 2019 Dec 21;40(48):3889-3897. doi: 10.1093/eurheartj/ehz766. PubMed 31761945 ↗
  • Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500. doi: 10.1002/cncr.22933. PubMed 17657815 ↗
  • Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497. PubMed 16983113 ↗
  • Jespersen CG, Norgaard M, Borre M. Androgen-deprivation therapy in treatment of prostate cancer and risk of myocardial infarction and stroke: a nationwide Danish population-based cohort study. Eur Urol. 2014 Apr;65(4):704-9. doi: 10.1016/j.eururo.2013.02.002. Epub 2013 Feb 12. PubMed 23433805 ↗
  • D'Amico AV, Denham JW, Crook J, Chen MH, Goldhaber SZ, Lamb DS, Joseph D, Tai KH, Malone S, Ludgate C, Steigler A, Kantoff PW. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol. 2007 Jun 10;25(17):2420-5. doi: 10.1200/JCO.2006.09.3369. PubMed 17557956 ↗
  • Voog JC, Paulus R, Shipley WU, Smith MR, McGowan DG, Jones CU, Bahary JP, Zeitzer KL, Souhami L, Leibenhaut MH, Rotman M, Husain SM, Gore E, Raben A, Chafe S, Sandler HM, Efstathiou JA. Cardiovascular Mortality Following Short-term Androgen Deprivation in Clinically Localized Prostate Cancer: An Analysis of RTOG 94-08. Eur Urol. 2016 Feb;69(2):204-10. doi: 10.1016/j.eururo.2015.08.027. Epub 2015 Sep 9. PubMed 26362090 ↗
  • Efstathiou JA, Bae K, Shipley WU, Hanks GE, Pilepich MV, Sandler HM, Smith MR. Cardiovascular mortality after androgen deprivation therapy for locally advanced prostate cancer: RTOG 85-31. J Clin Oncol. 2009 Jan 1;27(1):92-9. doi: 10.1200/JCO.2007.12.3752. Epub 2008 Dec 1. PubMed 19047297 ↗
  • Grossmann M, Hamilton EJ, Gilfillan C, Bolton D, Joon DL, Zajac JD. Bone and metabolic health in patients with non-metastatic prostate cancer who are receiving androgen deprivation therapy. Med J Aust. 2011 Mar 21;194(6):301-6. doi: 10.5694/j.1326-5377.2011.tb02979.x. PubMed 21426285 ↗
  • Morote J, Orsola A, Abascal JM, Planas J, Trilla E, Raventos CX, Cecchini L, Encabo G, Reventos J. Bone mineral density changes in patients with prostate cancer during the first 2 years of androgen suppression. J Urol. 2006 May;175(5):1679-83; discussion 1683. doi: 10.1016/S0022-5347(05)00999-7. PubMed 16600728 ↗
  • Smith MR, Lee WC, Brandman J, Wang Q, Botteman M, Pashos CL. Gonadotropin-releasing hormone agonists and fracture risk: a claims-based cohort study of men with nonmetastatic prostate cancer. J Clin Oncol. 2005 Nov 1;23(31):7897-903. doi: 10.1200/JCO.2004.00.6908. PubMed 16258089 ↗
  • Kokorovic A, So AI, Serag H, French C, Hamilton RJ, Izard JP, Nayak JG, Pouliot F, Saad F, Shayegan B, Aprikian A, Rendon RA. Canadian Urological Association guideline on androgen deprivation therapy: Adverse events and management strategies. Can Urol Assoc J. 2021 Jun;15(6):E307-E322. doi: 10.5489/cuaj.7355. No abstract available. PubMed 34127184 ↗
  • Daisley BA, Chanyi RM, Abdur-Rashid K, Al KF, Gibbons S, Chmiel JA, Wilcox H, Reid G, Anderson A, Dewar M, Nair SM, Chin J, Burton JP. Abiraterone acetate preferentially enriches for the gut commensal Akkermansia muciniphila in castrate-resistant prostate cancer patients. Nat Commun. 2020 Sep 24;11(1):4822. doi: 10.1038/s41467-020-18649-5. PubMed 32973149 ↗
  • van der Beek CM, Canfora EE, Lenaerts K, Troost FJ, Damink SWMO, Holst JJ, Masclee AAM, Dejong CHC, Blaak EE. Distal, not proximal, colonic acetate infusions promote fat oxidation and improve metabolic markers in overweight/obese men. Clin Sci (Lond). 2016 Nov 1;130(22):2073-2082. doi: 10.1042/CS20160263. Epub 2016 Jul 20. PubMed 27439969 ↗
  • Everard A, Belzer C, Geurts L, Ouwerkerk JP, Druart C, Bindels LB, Guiot Y, Derrien M, Muccioli GG, Delzenne NM, de Vos WM, Cani PD. Cross-talk between Akkermansia muciniphila and intestinal epithelium controls diet-induced obesity. Proc Natl Acad Sci U S A. 2013 May 28;110(22):9066-71. doi: 10.1073/pnas.1219451110. Epub 2013 May 13. PubMed 23671105 ↗
  • Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319. PubMed 32675291 ↗
  • Zhou Q, Zhang Y, Wang X, Yang R, Zhu X, Zhang Y, Chen C, Yuan H, Yang Z, Sun L. Gut bacteria Akkermansia is associated with reduced risk of obesity: evidence from the American Gut Project. Nutr Metab (Lond). 2020 Oct 22;17:90. doi: 10.1186/s12986-020-00516-1. eCollection 2020. PubMed 33110437 ↗
  • Luna M, Guss JD, Vasquez-Bolanos LS, Castaneda M, Rojas MV, Strong JM, Alabi DA, Dornevil SD, Nixon JC, Taylor EA, Donnelly E, Fu X, Shea MK, Booth SL, Bicalho R, Hernandez CJ. Components of the Gut Microbiome That Influence Bone Tissue-Level Strength. J Bone Miner Res. 2021 Sep;36(9):1823-1834. doi: 10.1002/jbmr.4341. Epub 2021 Jun 4. PubMed 33999456 ↗
  • Booth SL, Tucker KL, Chen H, Hannan MT, Gagnon DR, Cupples LA, Wilson PW, Ordovas J, Schaefer EJ, Dawson-Hughes B, Kiel DP. Dietary vitamin K intakes are associated with hip fracture but not with bone mineral density in elderly men and women. Am J Clin Nutr. 2000 May;71(5):1201-8. doi: 10.1093/ajcn/71.5.1201. PubMed 10799384 ↗
  • Evenepoel P, Dejongh S, Verbeke K, Meijers B. The Role of Gut Dysbiosis in the Bone-Vascular Axis in Chronic Kidney Disease. Toxins (Basel). 2020 Apr 29;12(5):285. doi: 10.3390/toxins12050285. PubMed 32365480 ↗
  • Mandatori D, Pelusi L, Schiavone V, Pipino C, Di Pietro N, Pandolfi A. The Dual Role of Vitamin K2 in "Bone-Vascular Crosstalk": Opposite Effects on Bone Loss and Vascular Calcification. Nutrients. 2021 Apr 7;13(4):1222. doi: 10.3390/nu13041222. PubMed 33917175 ↗
  • Arrieta MC, Bistritz L, Meddings JB. Alterations in intestinal permeability. Gut. 2006 Oct;55(10):1512-20. doi: 10.1136/gut.2005.085373. No abstract available. PubMed 16966705 ↗

Individual participant data

Plan to share: No — Our study protocol and analyses can be shared, but individual data will not.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802121
Lead sponsor
Western University
Responsible party
Melissa Huynh (Assistant Professor, Western University) — Principal investigator
First posted
Apr 6, 2023
Start date
Jul 2, 2025
Primary completion
Sep 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

Kaydee Connors
Contact
kaydee.connors@lhsc.on.ca
519-685-8500 ext. 56366
Stephen Mardell
Contact
stephen.mardell@lhsc.on.ca
519-685-8500 ext. 58448
Melissa Huynh, MD
principal investigator · Western University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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