Status:
RECRUITING
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
Lead Sponsor:
University of Miami
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06487507
Start Date
April 17 2025
End Date
May 1 2026
Last Update
April 30 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136