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NCT Number: NCT06487507

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Elena Cortizas, MS

CONTACT

[email protected]

3052433593

Nima Sharifi, MD

PRINCIPAL_INVESTIGATOR

Sanoj Punnen, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Fat Diet

Behavioral

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 diet

Behavioral

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.

Primary outcomes

  1. Proportion of patients consuming Mediterranean diet

    Time frame: Up to 2 weeks

    Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.

Secondary outcomes

  1. Change in fasting insulin

    Time frame: Baseline to 2 weeks

    Measured in milliliters

  2. Change in high-sensitivity c-reactive protein

    Time frame: Baseline to 2 weeks

    Measured in milligrams per liter

  3. Change in fasting glucose

    Time frame: Baseline to 2 weeks

    Measured in milligrams per deciliter

  4. Change in blood pressure

    Time frame: Baseline to 2 weeks

    Measured in millimeters of mercury

  5. Dietary behavior as measured by diet records questionnaire

    Time frame: Up to 2 weeks

    Measured in percentage of meals consumed by the participants

  6. Number of treatment related adverse events

    Time frame: Up to 2 weeks

    Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Cortizas, MS

CONTACT

[email protected]

3052433593

Nima Sharifi, MD

CONTACT

[email protected]

305-243-1350

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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