Overview
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.
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
Eligibility
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