Impact of Mediterranean Diet on Prostate Cancer Surgery Outcomes
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
This study tests whether following a Mediterranean-style diet can improve health and surgery results for men with prostate cancer before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06487507 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a controlled Mediterranean-style diet on fasting insulin levels and other measurable health indicators in men diagnosed with prostate cancer who are scheduled for robotic-assisted radical prostatectomy. Participants will follow either a low fat or lower carbohydrate diet prior to their surgery. Blood and tissue samples will be collected during surgery to assess the metabolic impact of the dietary interventions. The study aims to determine if dietary changes can influence surgical outcomes and overall health in this patient population.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 80 with a BMI between 18.5 and 40 who are scheduled for radical prostatectomy.
Not a fit: Patients currently following a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, or high fiber diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve surgical outcomes and metabolic health for prostate cancer patients.
How similar studies have performed: While there is ongoing research into dietary impacts on cancer treatment, this specific approach to a Mediterranean diet in pre-surgical prostate cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Nima Sharifi, MD — University of Miami
- Study coordinator: Nima Sharifi, MD
- Email: nimasharifi@miami.edu
- Phone: 305-243-1350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.