Recruiting

Mediterranean Diet

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05590624

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lower-Carbohydrate Med-t-Diet

Low-Fat Med-t-Diet

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05590624

Start date

Sep 3, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Mediterranean-type Diet(s)-Arm 1

Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after

experimental: Mediterranean-type Diet(s)-Arm 2

Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.

Interventions

Lower-Carbohydrate Med-t-Diet

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

Low-Fat Med-t-Diet

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

Primary outcome measure

  • Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism [ Time Frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy ]

Central Contacts and Locations

Central contacts

Myra Krnac

216-444-1047krnacm@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Myra Krnac

216-444-1047krnacm@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Mediterranean-type Diets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-02-19.