Recruiting

Mediterranean Diet

Sponsor:

University of Miami

Code:

NCT06487507

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low fat diet

Lower carbohydrate diet

Study Details

Brief summary:

The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.

Conditions

Prostate Cancer

Study ID

NCT06487507

Start date

Apr 17, 2025

Status verified date

Apr, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
  • BMI between 18.5 and 40
  • Ability to read, write, speak, and understand English and/or Spanish.
  • Ability to provide informed consent.
  • Willingness to consume provided dietary interventions.
  • Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. 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 as these diets are highly restrictive and may impact objectives/outcomes in the trial.
  • Previous intolerability to fiber-rich diets.
  • Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
  • Food allergies or other major dietary restrictions.
  • Receiving active medical treatment for Type I or Type II diabetes mellitus.
  • Recent weight loss or gain (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.
  • History of diabetic ketoacidosis.
  • History of Gout.
  • Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
  • Gallbladder removed or plan to remove per clinician evaluation.
  • Other malignancies actively receiving systemic treatment as per clinician evaluation.
  • Previous treatment for prostate cancer.
  • Previous history of pelvic radiation.
  • Patients with impaired decision-making capacity.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Low Fat Diet Group

Participants in this group will receive a low fat Mediterranean diet for 2 weeks.

experimental: Lower Carbohydrate Mediterranean Diet Group

Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.

Interventions

Low fat diet

Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) low fat Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates.

Lower carbohydrate diet

Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) lower carbohydrate Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates.

Primary outcome measure

  • Proportion of patients consuming Mediterranean diet [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

Central contacts

Nima Sharifi, MD

305-243-1350nimasharifi@miami.edu

Elena Cortizas, MS

3052433593ecortizas@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Elena Cortizas, MS

3052433593ecortizas@med.miami.edu

Principal Investigator:

Nima Sharifi, MD

More Information

Sponsor

University of Miami

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-23.