Akkermansia Muciniphilia and Metabolic Side Effects of ADT
ID: NCT05802121
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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.
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
Treatment Arms Description
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.
Observation group will follow standard of care treatment.
- 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
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
View Secondary Outcome Measures (29)
- Metabolic parameters: fasting plasma glucose — Time Frame: 3 months
Fasting plasma glucose (mmol/L)
- Metabolic parameters: fasting plasma glucose — Time Frame: 6 months
Fasting plasma glucose (mmol/L)
- Metabolic parameters: HbA1C — Time Frame: 3 months
HbA1c (%)
- Metabolic parameters: HbA1c — Time Frame: 6 months
HbA1c (%)
- Metabolic parameters: triglycerides — Time Frame: 3 months
Triglycerides (mmol/L)
- Metabolic parameters: triglycerides — Time Frame: 6 months
Triglycerides (mmol/L)
- Metabolic parameters: LDL cholesterol — Time Frame: 3 months
LDL cholesterol (mmol/L)
- Metabolic parameters: LDL cholesterol — Time Frame: 6 months
LDL cholesterol (mmol/L)
- Metabolic parameters: HDL cholesterol — Time Frame: 3 months
HDL cholesterol (mmol/L)
- Metabolic parameters: HDL cholesterol — Time Frame: 6 months
HDL cholesterol (mmol/L)
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
View Official Medical/Scientific Title
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer