Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05590624

Run by

Case Comprehensive Cancer Center

People needed

30

Starts

2024-09-03

Expected to finish

2026-12-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.