Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Korábbi kezelés

• Previous intolerability to fiber-rich diets
• 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
• Undergone any type of weight loss surgery
• 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
• Other malignancies actively receiving systemic treatment as per clinician evaluation

Más betegség

• Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion
• Food allergies or other major dietary restrictions
• History of diabetic ketoacidosis
• Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication)

Egyéb

• 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.
• Unwilling to undergo transperineal PCa biopsies
• Recent weight loss (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days
• Any medical contraindications as determined by investigators
• High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation
• Gout
• Gallbladder removed or plan to remove per clinician evaluation

• 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