search
Back to results

Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lower-Carbohydrate Med-t-Diet
Low-Fat Med-t-Diet
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring Mediterranean-type Diets

Eligibility Criteria

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

Inclusion Criteria:

  • Males ≥18 years old
  • High suspicion of prostate cancer (PCa) per urologist's clinical evaluation
  • BMI >18.5
  • No prior PCa diagnosis or hormonal therapy (-ies)
  • Ability to read, write, speak, and understand English
  • Ability to provide informed consent
  • Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive
  • Willingness to consume provided dietary interventions
  • Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥9 g/dL (transfusions permitted), Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN) (for subjects with Gilbert's disease ≤3.0 mg/dL), Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN, Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation

Exclusion Criteria:

  • Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators.
  • Previous intolerability to fiber-rich diets
  • Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion
  • Unwilling to undergo transperineal PCa biopsies
  • Food allergies or other major dietary restrictions
  • Receiving active medical treatment for Type I or Type II diabetes mellitus
  • Prior antibiotic usage (i.e. within last 30 days) at time of consent
  • Recent weight loss (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days
  • Undergone any type of weight loss surgery
  • Any medical contraindications as determined by investigators
  • High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation
  • History of diabetic ketoacidosis
  • Gout
  • Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion
  • Recent (within last 30 days) device implant/joint requiring antibiotics as per clinician determination
  • Prior history of prostate biopsy infection
  • Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication)
  • Gallbladder removed or plan to remove per clinician evaluation
  • Other malignancies actively receiving systemic treatment as per clinician evaluation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mediterranean-type Diet(s)-Arm 1

    Mediterranean-type Diet(s)-Arm 2

    Arm Description

    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after

    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.

    Outcomes

    Primary Outcome Measures

    Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
    Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure.

    Secondary Outcome Measures

    Changes in blood metabolomics
    Change in blood metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure
    Changes in energy substrate(s)
    Change measured by respiratory exchange ratio (VCO2/VO2) difference between baseline and at two weeks on diet
    Changes in blood glucose (mg/dL)
    Change as measured by the difference between blood glucose levels at baseline and at week two on diet
    Changes in ketone levels (mM or mcg/mL)
    Change measured by the difference between ketone levels between baseline and at two weeks on diet
    Changes in hemoglobin A1C (HbA1C) (%)
    Change measured by the difference between A1C levels at baseline and at 2 weeks on diet
    Changes in C-reactive protein (CRP) (mg/L)
    Change measured by the difference between CRP levels at baseline and at 2 weeks on diet
    Changes in lipid particle size (nm)
    Change measured by the difference in lipid particle size at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR).
    Changes in lipid particle number (nmol/L and/or μmol/L)
    Change measured by the difference in lipid particle number at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR)
    Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
    Change as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score using fasting insulin and glucose from longitudinal blood specimens at baseline and at two weeks on diet. The HOMA-IR test tests how resistant a participant is to insulin. A score of less than 1 indicates that a participant is insulin-sensitive, a score greater than 1.9 indicates some insulin resistance, and a score greater than 2.9 indicates significant insulin resistance.
    Prostate health changes
    As measured by changes in the Prostate Health Index
    Safety and tolerability of the diets
    Safety and tolerability measured by the number of adverse events and by the gastric tolerance questionnaire
    Changes in alpha and beta diversity of the gut microbiome
    Changes measured by Shannon or Simpson diversity index (alpha diversity) and pairwise Bray-Curtis metric values (beta diversity)
    Changes in dietary behavior
    Behavioral changes measured by validated 24 hour dietary recalls collected by trained dietetics personnel on 2 week days and 1 weekend to capture specific dietary information
    Diet compliance
    Compliance measured by >90% of provided calories consumed

    Full Information

    First Posted
    September 23, 2022
    Last Updated
    August 15, 2023
    Sponsor
    Case Comprehensive Cancer Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05590624
    Brief Title
    Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
    Official Title
    Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer. The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.
    Detailed Description
    Primary Objective -Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism Secondary Objectives Evaluate the impact of Med-t-Diets on host metabolism Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Mediterranean-type Diets

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Patients will be randomized to one of two arms which only differ in the order they will receive the two dietary interventions [Lower Carbohydrate (LC) and Low Fat (LF)]. All dietary interventions are on a Mediterranean foundation and are opposite in carbohydrate and fat content. Arm 1 [n=15 with confirmed PCa diagnosis and candidate for Active Surveillance (AS) per Standard of Care (SOC)]: Dietary Intervention #1=Low Fat (LF) Mediterranean. Dietary Intervention #2=Lower Carbohydrate (LC) Mediterranean Arm 2 (n=15 with confirmed PCa diagnosis and candidate for AS per SOC): Dietary Intervention #1=LC Mediterranean. Dietary Intervention #2=LF Mediterranean
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mediterranean-type Diet(s)-Arm 1
    Arm Type
    Experimental
    Arm Description
    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after
    Arm Title
    Mediterranean-type Diet(s)-Arm 2
    Arm Type
    Experimental
    Arm Description
    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.
    Intervention Type
    Other
    Intervention Name(s)
    Lower-Carbohydrate Med-t-Diet
    Intervention Description
    Diet will focus on including: Lean protein sources High-quality fat High-quality carbohydrate sources that are rich in fiber Nuts and seeds Diet will focus on limiting: Refined sugars High glycemic carbohydrates Seed oils that may cause inflammation Diet Composition: 45% fats, 35% carbs, 20% protein
    Intervention Type
    Other
    Intervention Name(s)
    Low-Fat Med-t-Diet
    Intervention Description
    Diet will focus on including: Lean protein sources High-quality fat High-quality carbohydrate sources that are rich in fiber Nuts and seeds Diet will focus on limiting: Refined sugars High glycemic carbohydrates Seed oils that may cause inflammation Diet Composition: 70% carbs, 20% protein, 10% fat
    Primary Outcome Measure Information:
    Title
    Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
    Description
    Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure.
    Time Frame
    Change from diagnostic biopsy (Week 2) at confirmatory biopsy
    Secondary Outcome Measure Information:
    Title
    Changes in blood metabolomics
    Description
    Change in blood metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in energy substrate(s)
    Description
    Change measured by respiratory exchange ratio (VCO2/VO2) difference between baseline and at two weeks on diet
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in blood glucose (mg/dL)
    Description
    Change as measured by the difference between blood glucose levels at baseline and at week two on diet
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in ketone levels (mM or mcg/mL)
    Description
    Change measured by the difference between ketone levels between baseline and at two weeks on diet
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in hemoglobin A1C (HbA1C) (%)
    Description
    Change measured by the difference between A1C levels at baseline and at 2 weeks on diet
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in C-reactive protein (CRP) (mg/L)
    Description
    Change measured by the difference between CRP levels at baseline and at 2 weeks on diet
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in lipid particle size (nm)
    Description
    Change measured by the difference in lipid particle size at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR).
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in lipid particle number (nmol/L and/or μmol/L)
    Description
    Change measured by the difference in lipid particle number at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR)
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
    Description
    Change as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score using fasting insulin and glucose from longitudinal blood specimens at baseline and at two weeks on diet. The HOMA-IR test tests how resistant a participant is to insulin. A score of less than 1 indicates that a participant is insulin-sensitive, a score greater than 1.9 indicates some insulin resistance, and a score greater than 2.9 indicates significant insulin resistance.
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Prostate health changes
    Description
    As measured by changes in the Prostate Health Index
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Safety and tolerability of the diets
    Description
    Safety and tolerability measured by the number of adverse events and by the gastric tolerance questionnaire
    Time Frame
    Through study completion, an average of 7.5 month
    Title
    Changes in alpha and beta diversity of the gut microbiome
    Description
    Changes measured by Shannon or Simpson diversity index (alpha diversity) and pairwise Bray-Curtis metric values (beta diversity)
    Time Frame
    Change from baseline at two weeks on diet
    Title
    Changes in dietary behavior
    Description
    Behavioral changes measured by validated 24 hour dietary recalls collected by trained dietetics personnel on 2 week days and 1 weekend to capture specific dietary information
    Time Frame
    Through study completion, an average of 7.5 months
    Title
    Diet compliance
    Description
    Compliance measured by >90% of provided calories consumed
    Time Frame
    throughout controlled feeding period(s), two weeks per diet

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males ≥18 years old High suspicion of prostate cancer (PCa) per urologist's clinical evaluation BMI >18.5 No prior PCa diagnosis or hormonal therapy (-ies) Ability to read, write, speak, and understand English Ability to provide informed consent Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive Willingness to consume provided dietary interventions Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥9 g/dL (transfusions permitted), Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN) (for subjects with Gilbert's disease ≤3.0 mg/dL), Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN, Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation Exclusion Criteria: Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators. Previous intolerability to fiber-rich diets Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion Unwilling to undergo transperineal PCa biopsies Food allergies or other major dietary restrictions Receiving active medical treatment for Type I or Type II diabetes mellitus Prior antibiotic usage (i.e. within last 30 days) at time of consent Recent weight loss (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days Undergone any type of weight loss surgery Any medical contraindications as determined by investigators High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation History of diabetic ketoacidosis Gout Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion Recent (within last 30 days) device implant/joint requiring antibiotics as per clinician determination Prior history of prostate biopsy infection Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication) Gallbladder removed or plan to remove per clinician evaluation Other malignancies actively receiving systemic treatment as per clinician evaluation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dianna Sendrey, RN, BSN
    Phone
    (216) 444-0486
    Email
    sendred2@ccf.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Weight, MD
    Organizational Affiliation
    Center Director, Cleveland Clinic Urologic Oncology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30664736
    Citation
    Freedland SJ, Howard L, Allen J, Smith J, Stout J, Aronson W, Inman BA, Armstrong AJ, George D, Westman E, Lin PH. A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial. Prostate Cancer Prostatic Dis. 2019 Sep;22(3):428-437. doi: 10.1038/s41391-019-0126-5. Epub 2019 Jan 21.
    Results Reference
    background
    PubMed Identifier
    16094059
    Citation
    Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
    Results Reference
    background

    Learn more about this trial

    Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

    We'll reach out to this number within 24 hrs