Prostate cancer patients try mediterranean diet before surgery

NCT ID NCT06487507

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether eating a controlled Mediterranean diet before prostate cancer surgery can improve health markers like insulin levels. Twenty men scheduled for prostate removal will receive pre-made meals and be monitored. The goal is to see if this diet is practical and has any positive effects on blood and tissue samples.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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