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

Clinicaltrials.gov ID: NCT06487507
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 18 - 80 Years
b-bullseye-arrow Enrollments 20

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Nima Sharifi, MD

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.

Study Plan

Low Fat Diet Group

EXPERIMENTAL

Participants in this group will receive a low fat Mediterranean diet for 2 weeks.

  • BEHAVIORAL:

    Low fat diet

    Description:

    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 others, and will limit refined sugars and high glycemic carbohydrates.

Lower Carbohydrate Mediterranean Diet Group

EXPERIMENTAL

Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.

  • BEHAVIORAL:

    Lower carbohydrate diet

    Description:

    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 among others, and will limit refined sugars and high glycemic carbohydrates.

Outcome Measures

Primary Outcome Measures

Proportion of patients consuming Mediterranean diet

Time Frame: Up to 2 weeks

Secondary Outcome Measures

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

Timeline

  • Last Updated
    April 30, 2025
  • Start Date
    July 5, 2024
  • Today
    October 27, 2025
  • Completion Date ( Estimated )
    May 1, 2026

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