Prostate cancer patients try mediterranean diet before surgery
NCT ID NCT06487507
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?