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

Overview

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.

Interventions

• Behavioral Low fat diet
  Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) low fat Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among other
• Behavioral Lower carbohydrate diet
  Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) lower carbohydrate Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources

Primary outcome measures

• Proportion of patients consuming Mediterranean diet [Time frame: Up to 2 weeks]

Secondary outcome measures (6)

• Change in fasting insulin [Time frame: Baseline to 2 weeks]
• Change in high-sensitivity c-reactive protein [Time frame: Baseline to 2 weeks]
• Change in fasting glucose [Time frame: Baseline to 2 weeks]
• Change in blood pressure [Time frame: Baseline to 2 weeks]
• Dietary behavior as measured by diet records questionnaire [Time frame: Up to 2 weeks]
• Number of treatment related adverse events [Time frame: Up to 2 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Miami — Miami

Identifiers

NCT: NCT06487507 · 20240052

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗