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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a controlled Mediterranean-style diet before prostate cancer surgery changes insulin levels measured after fasting (not eating) and other measures in blood and tissue. It is for men with prostate cancer who are scheduled for robot-assisted surgery to remove the prostate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 18 to 80 scheduled for surgery to remove the prostate as part of their usual care.
  • Have a body mass index (BMI), a measure of weight compared with height, between 18.5 and 40.
  • Can read, write, speak, and understand English and/or Spanish.
  • Can understand the study and give consent to join.
  • Willing to eat the foods provided by the study.
  • Have blood cell counts and liver and kidney function that meet the study’s limits, as checked by your care team.

Who can't join

  • Already follow a Mediterranean, low-carb, ketogenic, vegan, vegetarian, or high-fiber diet, or take supplements that the study team says could affect the study diets.
  • Have trouble tolerating high-fiber diets, bowel inflammation, irritable bowel syndrome, another digestive condition, food allergies, or other major food restrictions.
  • Are receiving medical treatment for type 1 or type 2 diabetes; have had diabetic ketoacidosis (dangerous acid buildup linked to diabetes) or gout.
  • Gained or lost 5% or more of your body weight in the past 30 days, or have had weight-loss surgery.
  • Have a weakened immune system, have had or plan to have your gallbladder removed, or have another medical reason the study team says makes joining unsafe.
  • Are receiving treatment that acts throughout the body for another cancer.
  • Have had treatment for prostate cancer or radiation to the pelvis (lower belly area).
  • Have trouble making informed decisions.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

FL