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

Launched by UNIVERSITY OF MIAMI · Jun 27, 2024

Keywords

ClinConnect Summary

The PROVISIONS trial is a study designed to see how following a Mediterranean-style diet before prostate cancer surgery might affect certain health markers, like insulin levels, in patients scheduled for surgery. This diet includes healthy foods like fruits, vegetables, whole grains, and healthy fats, which could potentially help improve patients' health before their operation.

To participate in this study, men aged 18 to 80 who are planning to undergo radical prostatectomy surgery may be eligible, provided they meet certain health criteria, such as having a body mass index (BMI) within a specific range and good organ function. Participants will be asked to follow the provided diet and will have their blood and tissue samples tested during surgery to see how the diet impacts their health. It’s important to note that those with certain dietary restrictions or medical conditions may not qualify for this trial. If you or someone you know is interested, it’s a great opportunity to contribute to research that could benefit future patients with prostate cancer.

Gender

MALE

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.