Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
Recruiting · NCT06487507 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Low fat dietLower carbohydrate diet
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.
Who can take part
Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States