Prostate CancerEarly Phase 1NCT05802121
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
A Early Phase 1 study testing Apple Cider Vinegar in people with Prostate Cancer and Metabolic Syndrome, run by Western University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metabolic Syndrome, Obesity
- What is being tested?
- Apple Cider Vinegar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2025to Jun 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A5W9
About this study
Official title: The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
The overriding objectives of this study are:
- Primary outcomes:
- 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.
- To confirm tolerability and assess for side effects of oral acetate supplementation.
- Secondary outcomes:
- 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
- Being tested
- Apple Cider Vinegar
- Keywords
- prostate cancer, metabolic syndrome, androgen deprivation therapy, microbiome, Akkermansias muciniphilia, cardiovascular disease
- Medical subject headings
- Prostatic Neoplasms, Metabolic Syndrome, Obesity, Bone Diseases, Hyperlipidemias, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Cider VinegarDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Apple Cider Vinegar | Experimental | 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. Receives: Drug: Apple Cider Vinegar |
| Observation | No intervention | Observation group will follow standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Akkermansia muciniphilia counts
Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.
Measured: 1 week
Fecal Akkermansia muciniphilia counts
Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.
Measured: 1 month
Fecal Akkermansia muciniphilia counts
Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.
Measured: 3 month
Fecal Akkermansia muciniphilia counts
Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.
Measured: 4 month
Fecal Akkermansia muciniphilia counts
Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.
Measured: 6 month
Side effects and tolerability
We will record side effects reported by the participants and the rate of Discontinuation of the intervention.
Measured: 3 months
Secondary outcomes (29)
Metabolic parameters: fasting plasma glucose
Fasting plasma glucose (mmol/L)
Measured: 3 months
Metabolic parameters: fasting plasma glucose
Fasting plasma glucose (mmol/L)
Measured: 6 months
Metabolic parameters: HbA1C
HbA1c (%)
Measured: 3 months
Metabolic parameters: HbA1c
HbA1c (%)
Measured: 6 months
Metabolic parameters: triglycerides
Triglycerides (mmol/L)
Measured: 3 months
Metabolic parameters: triglycerides
Triglycerides (mmol/L)
Measured: 6 months
Metabolic parameters: LDL cholesterol
LDL cholesterol (mmol/L)
Measured: 3 months
Metabolic parameters: LDL cholesterol
LDL cholesterol (mmol/L)
Measured: 6 months
Metabolic parameters: HDL cholesterol
HDL cholesterol (mmol/L)
Measured: 3 months
Metabolic parameters: HDL cholesterol
HDL cholesterol (mmol/L)
Measured: 6 months
Metabolic parameters: total cholesterol
Total cholesterol (mmol/L)
Measured: 3 months
Metabolic parameters: total cholesterol
Total cholesterol (mmol/L)
Measured: 6 months
Metabolic parameters: PSA
PSA (ng/mL)
Measured: 6 months
Metabolic parameters: PSA
PSA (ng/mL)
Measured: 3 months
Metabolic parameters: hemoglobin
Hemoglobin (g/L)
Measured: 3 months
Metabolic parameters: hemoglobin
Hemoglobin (g/L)
Measured: 6 months
Metabolic parameters: serum creatinine
Serum creatinine (µmol/L)
Measured: 3 months
Metabolic parameters: serum calcium
Serum calcium (µmol/L)
Measured: 3 months
Metabolic parameters: serum calcium
Serum calcium (µmol/L)
Measured: 6 months
Metabolic parameters: alanine transferase
Alanine transferase (U/L)
Measured: 3 months
Metabolic parameters: alanine transferase
Alanine transferase (U/L)
Measured: 6 months
Metabolic parameters: aspartate aminotransferase
Aspartate aminotransferase (U/L)
Measured: 3 months
Metabolic parameters: aspartate aminotransferase
Aspartate aminotransferase (U/L)
Measured: 6 months
Metabolic parameters: Insulin resistance index (HOMA IR)
Insulin resistance index (HOMA IR)
Measured: 3 months
Metabolic parameters: HOMA IR
Insulin resistance index (HOMA IR)
Measured: 6 months
Bone health: dp-ucMGP levels
Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline
Measured: 3 months
Bone health: dp-ucMGP levels
Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline
Measured: 6 months
Bone health: Vitamin K2
Vitamin K2 levels
Measured: 3 months
Bone health: Vitamin K2
Vitamin K2 levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start2 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single-institution, randomized controlled trial involving men ≥18 years of age with metastatic castration-sensitive prostate cancer. This study will require histologic confirmation of prostate adenocarcinoma and radiographic evidence of metastatic disease on either conventional imaging (CT and BS) or PSMA PET scan. Patients will be randomized 1:1 to receive acetate supplementation or observation. Our institution sees approximately 200 new metastatic prostate cancer patients each year, therefore, the investigators do not anticipate encountering difficulties with recruitment into this study over a period of 2 years.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Huynh, Western University
- Investigators
- Melissa Huynh, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802121
- Sponsor's protocol ID
- ReDA ID 12558
- Status last verified
- Aug 2025
- First submitted
- 12 Mar 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study protocol and analyses can be shared, but individual data will not.
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 32412803Smith 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 11836291Timilshina 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 23083859Braga-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 16921050Seible 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 24726149Sturgeon 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 31761945Saigal 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 17657815Keating 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 16983113Jespersen 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 23433805D'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 17557956Voog 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 26362090Efstathiou 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 19047297Grossmann 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 21426285Morote 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 16600728Smith 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