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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Nima Sharifi, MD
nimasharifi@miami.edu
305-243-1350
Backup
Elena Cortizas, MS
ecortizas@med.miami.edu
3052433593
Time Frame
Start Date: 2025-04-17
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov