Home › Trials › NCT05590624
Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Impact of Mediterranean Diets on Prostate Cancer Metabolism

Official title: Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)

Run by Case Comprehensive Cancer Center · NCT05590624 · Data updated 2026-11-12

This study tests whether following a Mediterranean diet can help men with localized prostate cancer by looking at how it affects their metabolism and overall health.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment30 (estimated)
SponsorCase Comprehensive Cancer Center
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedSeptember 3, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedFebruary 19, 2026
Trial IDNCT05590624 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males aged 18 and older with a high suspicion of prostate cancer who are eligible for active surveillance.

Probably not a fit

Patients with a prior diagnosis of prostate cancer or those currently following a Mediterranean, lower carbohydrate, ketogenic, vegan, or vegetarian diet may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines how Mediterranean-type diets affect the metabolism of men diagnosed with localized prostate cancer. It aims to evaluate the effects of these diets on non-malignant prostate tissue, host metabolism, systemic biomarkers, and the microbiome. Participants will be assigned to either a lower-carbohydrate or low-fat Mediterranean diet and their dietary behavior and compliance will also be assessed. The study seeks to provide insights into the optimal dietary approach for managing prostate cancer.

Why it matters

Potential benefit: If successful, this study could identify dietary interventions that improve metabolic health and outcomes for men with prostate cancer.

How similar studies have gone: While dietary interventions in cancer treatment are being explored, this specific approach focusing on Mediterranean diets in prostate cancer is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Case Comprehensive Cancer Center, Cleveland Clinic Foundation
    Cleveland, Ohio, United States     Recruiting

Study contacts

  • Principal investigator: Christopher Weight, MD — Center Director, Cleveland Clinic Urologic Oncology
  • Study coordinator: Myra Krnac
  • Email: krnacm@ccf.org
  • Phone: 216-444-1047

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Prostate Cancer 1464Case Comprehensive Cancer Center 64
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.