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

NCT ID: NCT06487507

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2026-05-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low Fat Diet Group

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

Group Type: EXPERIMENTAL

Low fat diet

Intervention Type: BEHAVIORAL

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 Mediterranean Diet Group

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

Group Type: EXPERIMENTAL

Lower carbohydrate diet

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Nima Sharifi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nima Sharifi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nima Sharifi, MD

Role: CONTACT

nimasharifi@miami.edu

305-243-1350

Elena Cortizas, MS

Role: CONTACT

ecortizas@med.miami.edu

3052433593

Facility Contacts

Elena Cortizas, MS

Role: primary

ecortizas@med.miami.edu

3052433593

Other Identifiers

20240052

Identifier Type: -

Identifier Source: org_study_id