Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Low fat diet; Behavioral: Lower carbohydrate diet

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nima Sharifi, MD; Phone Number: 305-243-1350; Email: nimasharifi@miami.edu
• Study Contact Backup: Name: Elena Cortizas, MS; Phone Number: 3052433593; Email: ecortizas@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Elena Cortizas, MS; Phone Number: 3052433593; Email: ecortizas@med.miami.edu
      • Principal Investigator: Nima Sharifi, MD
      • Sub-Investigator: Sanoj Punnen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Fat Diet Group; Participants in this group will receive a low fat Mediterranean diet for 2 weeks.	Behavioral: 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.
Experimental: Lower Carbohydrate Mediterranean Diet Group; Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients consuming Mediterranean diet	Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting insulin	Measured in milliliters	Baseline to 2 weeks
Change in high-sensitivity c-reactive protein	Measured in milligrams per liter	Baseline to 2 weeks
Change in fasting glucose	Measured in milligrams per deciliter	Baseline to 2 weeks
Change in blood pressure	Measured in millimeters of mercury	Baseline to 2 weeks
Dietary behavior as measured by diet records questionnaire	Measured in percentage of meals consumed by the participants	Up to 2 weeks
Number of treatment related adverse events	Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Nima Sharifi, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Fat-Restricted
• Other Study ID Numbers: 20240052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No