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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Low fat diet; Behavioral: Lower carbohydrate diet

• Registration Number: NCT06487507
• Lead Sponsor: University of Miami

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 insulin levels and other values that can be measured in blood and tissue samples from surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Status Verified: 2025-01
• Study Start: 2025-04-17
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Fat Diet Group	Low fat diet	Participants in this group will receive a low fat Mediterranean diet for 2 weeks.
Lower Carbohydrate Mediterranean Diet Group	Lower carbohydrate diet	Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of patients consuming Mediterranean diet	Up to 2 weeks	Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.

Secondary Outcome Measures

Name	Time	Method
Change in high-sensitivity c-reactive protein	Baseline to 2 weeks	Measured in milligrams per liter
Change in fasting insulin	Baseline to 2 weeks	Measured in milliliters
Change in fasting glucose	Baseline to 2 weeks	Measured in milligrams per deciliter
Change in blood pressure	Baseline to 2 weeks	Measured in millimeters of mercury
Dietary behavior as measured by diet records questionnaire	Up to 2 weeks	Measured in percentage of meals consumed by the participants
Number of treatment related adverse events	Up to 2 weeks	Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States