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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
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
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
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGEvaluate 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.
Time frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
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
Time frame: Change from baseline at two weeks on diet
Changes in energy substrate(s)
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
Changes in blood glucose (mg/dL)
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
Changes in ketone levels (mM or mcg/mL)
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
Changes in hemoglobin A1C (HbA1C) (%)
Change measured by the difference between A1C levels at baseline and at 2 weeks on diet
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Time frame: Change from baseline at two 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
Time frame: Change from baseline at two 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).
Time frame: Change from baseline at two weeks on diet
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)
Time frame: Change from baseline at two weeks on diet
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.
Time frame: Change from baseline at two weeks on diet
Prostate health changes
As measured by changes in the Prostate Health Index
Time frame: Change from baseline at two weeks on diet
Safety and tolerability of the diets
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
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)
Time frame: Change from baseline at two weeks on diet
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
Time frame: Through study completion, an average of 7.5 months
Diet compliance
Compliance measured by \>90% of provided calories consumed
Time frame: throughout controlled feeding period(s), two weeks per diet