Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
NCT06487507

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

Led by University of Miami · Updated on 2026-04-23

20

Participants Needed

1

Research Sites

106 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Males aged 18 to 80 years scheduled for radical prostatectomy surgery as part of standard care
  • Body mass index (BMI) between 18.5 and 40
  • Ability to read, write, speak, and understand English or Spanish
  • Ability to provide informed consent
  • Willingness to consume the provided dietary interventions
  • Adequate organ and marrow function as assessed by clinician, including: white blood cell count ≥2,500/microliter; absolute neutrophil count ≥1,500/microliter; platelets ≥100,000/microliter; hemoglobin ≥9 g/dL (transfusions allowed); total bilirubin ≤1.5 times institutional upper limit of normal (ULN) or ≤3.0 mg/dL for Gilbert's disease; AST/ALT ≤2.5 times ULN; creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation
Not Eligible

You will not qualify if you...

  • Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, or high fiber diet (>14g fiber per 1,000 Calories) or supplements that interfere with study diets
  • Previous intolerance to fiber-rich diets
  • Diagnosed colitis, irritable bowel syndrome, or other gastrointestinal conditions as determined by clinician
  • Food allergies or major dietary restrictions
  • Receiving active treatment for Type I or Type II diabetes mellitus
  • Recent weight change of 5% or more in the last 30 days (intentional or unintentional)
  • Previous weight loss surgery
  • Any medical contraindications as determined by investigators
  • History of diabetic ketoacidosis or gout
  • Immunosuppressed patients (e.g., transplant history, on immunosuppression) as per clinician discretion
  • Gallbladder removed or planned removal
  • Other malignancies actively receiving systemic treatment
  • Previous treatment for prostate cancer
  • Previous pelvic radiation
  • Patients with impaired decision-making capacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

N

Nima Sharifi, MD

CONTACT

E

Elena Cortizas, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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