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Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Primary Purpose

Prostate Cancer, Metabolic Syndrome, Obesity

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Apple Cider Vinegar
Placebo
Sponsored by
Western University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, metabolic syndrome, androgen deprivation therapy, microbiome, Akkermansias muciniphilia, cardiovascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 conventional imaging with CT of the abdomen, and pelvis and bone scan. Exclusion Criteria: 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 Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter) Inadequate liver function

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Apple Cider Vinegar

    Placebo

    Arm Description

    Webbers Natural apple cider vinegar pills (NPN: 80021269), enteric coated. Each patient will be instructed to take 6 enteric slow-release acetate capsules (equivalent of 500 mg/ capsule containing 25 mg acetate x 6 capsules) per day for 3 months.

    Placebo pills will be provided by our hospital pharmacy, and patients will be given the same instructions as in the treatment arm.

    Outcomes

    Primary Outcome Measures

    Fecal Akkermansia muciniphilia counts
    Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.
    Fecal Akkermansia muciniphilia counts
    Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.
    Fecal Akkermansia muciniphilia counts
    Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.
    Fecal Akkermansia muciniphilia counts
    Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.
    Fecal Akkermansia muciniphilia counts
    Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.
    Side effects and tolerability
    We will record side effects reported by the participants and the rate of Discontinuation of the intervention.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 12, 2023
    Last Updated
    March 24, 2023
    Sponsor
    Western University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05802121
    Brief Title
    Akkermansia Muciniphilia and Metabolic Side Effects of ADT
    Official Title
    The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 placebo. To confirm tolerability and assess for side effects of delayed oral acetate supplementation. Secondary outcomes: To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity, Bone Diseases, Hyperlipidemias, Diabetes
    Keywords
    prostate cancer, metabolic syndrome, androgen deprivation therapy, microbiome, Akkermansias muciniphilia, cardiovascular disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    This will be a single-institution, randomized placebo-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 conventional imaging (CT or BS). Patients will be randomized 1:1 to receive acetate supplementation or placebo. 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
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Both participants and investigators will be blinded to the intervention, either the apple cider vinegar pills vs. acetate.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apple Cider Vinegar
    Arm Type
    Experimental
    Arm Description
    Webbers Natural apple cider vinegar pills (NPN: 80021269), enteric coated. Each patient will be instructed to take 6 enteric slow-release acetate capsules (equivalent of 500 mg/ capsule containing 25 mg acetate x 6 capsules) per day for 3 months.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pills will be provided by our hospital pharmacy, and patients will be given the same instructions as in the treatment arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Apple Cider Vinegar
    Intervention Description
    Each patient will be instructed to take 6 enteric slow-release acetate capsules (equivalent of 500 mg/ capsule containing 25 mg acetate x 6 capsules) per day for 3 months https://www.webbernaturals.com/en-ca/apple-cider-vinegar-500-mg-capsules/
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Each patient will be instructed to take 6 placebo capsules per day for 3 months
    Primary Outcome Measure Information:
    Title
    Fecal Akkermansia muciniphilia counts
    Description
    Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.
    Time Frame
    1 week
    Title
    Fecal Akkermansia muciniphilia counts
    Description
    Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.
    Time Frame
    1 month
    Title
    Fecal Akkermansia muciniphilia counts
    Description
    Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.
    Time Frame
    3 month
    Title
    Fecal Akkermansia muciniphilia counts
    Description
    Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.
    Time Frame
    4 month
    Title
    Fecal Akkermansia muciniphilia counts
    Description
    Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.
    Time Frame
    6 month
    Title
    Side effects and tolerability
    Description
    We will record side effects reported by the participants and the rate of Discontinuation of the intervention.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Metabolic parameters: fasting plasma glucose
    Description
    Fasting plasma glucose (mmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: fasting plasma glucose
    Description
    Fasting plasma glucose (mmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: HbA1C
    Description
    HbA1c (%)
    Time Frame
    3 months
    Title
    Metabolic parameters: HbA1c
    Description
    HbA1c (%)
    Time Frame
    6 months
    Title
    Metabolic parameters: triglycerides
    Description
    Triglycerides (mmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: triglycerides
    Description
    Triglycerides (mmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: LDL cholesterol
    Description
    LDL cholesterol (mmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: LDL cholesterol
    Description
    LDL cholesterol (mmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: HDL cholesterol
    Description
    HDL cholesterol (mmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: HDL cholesterol
    Description
    HDL cholesterol (mmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: total cholesterol
    Description
    Total cholesterol (mmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: total cholesterol
    Description
    Total cholesterol (mmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: PSA
    Description
    PSA (ng/mL)
    Time Frame
    6 months
    Title
    Metabolic parameters: PSA
    Description
    PSA (ng/mL)
    Time Frame
    3 months
    Title
    Metabolic parameters: hemoglobin
    Description
    Hemoglobin (g/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: hemoglobin
    Description
    Hemoglobin (g/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: serum creatinine
    Description
    Serum creatinine (µmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: serum calcium
    Description
    Serum calcium (µmol/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: serum calcium
    Description
    Serum calcium (µmol/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: alanine transferase
    Description
    Alanine transferase (U/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: alanine transferase
    Description
    Alanine transferase (U/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: aspartate aminotransferase
    Description
    Aspartate aminotransferase (U/L)
    Time Frame
    3 months
    Title
    Metabolic parameters: aspartate aminotransferase
    Description
    Aspartate aminotransferase (U/L)
    Time Frame
    6 months
    Title
    Metabolic parameters: Insulin resistance index (HOMA IR)
    Description
    Insulin resistance index (HOMA IR)
    Time Frame
    3 months
    Title
    Metabolic parameters: HOMA IR
    Description
    Insulin resistance index (HOMA IR)
    Time Frame
    6 months
    Title
    Bone health: dp-ucMGP levels
    Description
    Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline
    Time Frame
    3 months
    Title
    Bone health: dp-ucMGP levels
    Description
    Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline
    Time Frame
    6 months
    Title
    Bone health: Vitamin K2
    Description
    Vitamin K2 levels
    Time Frame
    3 months
    Title
    Bone health: Vitamin K2
    Description
    Vitamin K2 levels
    Time Frame
    6 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 conventional imaging with CT of the abdomen, and pelvis and bone scan. Exclusion Criteria: 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 Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter) Inadequate liver function
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kaydee Connors
    Phone
    519-685-8500
    Ext
    56366
    Email
    kaydee.connors@lhsc.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicole Phillips
    Phone
    519-685-8500
    Ext
    56366
    Email
    nicole.phillips@lhsc.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa Huynh, MD
    Organizational Affiliation
    Western University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Our study protocol and analyses can be shared, but individual data will not.
    Citations:
    PubMed Identifier
    32412803
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11836291
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23083859
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16921050
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24726149
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31761945
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17657815
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16983113
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23433805
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17557956
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26362090
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19047297
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21426285
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16600728
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16258089
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34127184
    Citation
    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. Erratum In: Can Urol Assoc J. 2021 Jul;15(7):E383.
    Results Reference
    background
    PubMed Identifier
    32973149
    Citation
    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. Erratum In: Nat Commun. 2020 Dec 9;11(1):6394.
    Results Reference
    background
    PubMed Identifier
    27439969
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23671105
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32675291
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33110437
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33999456
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10799384
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32365480
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33917175
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16966705
    Citation
    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.
    Results Reference
    background

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    Akkermansia Muciniphilia and Metabolic Side Effects of ADT

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