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Trial Title:
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
NCT ID:
NCT06487507
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Low fat diet
Description:
Prior to surgery, participants complete diet records for 7 days. After, they 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 their 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.
Arm group label:
Low Fat Diet Group
Intervention type:
Behavioral
Intervention name:
Lower carbohydrate diet
Description:
Prior to surgery, participants complete diet records for 7 days. After, they 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 their 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.
Arm group label:
Lower Carbohydrate Mediterranean Diet Group
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.
Criteria for 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.
- Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or
without medication).
- 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Elena Cortizas, MS
Phone:
3052433593
Email:
ecortizas@med.miami.edu
Contact backup:
Last name:
Nima Sharifi, MD
Contact backup:
Last name:
Sanoj Punnen, MD
Start date:
January 1, 2025
Completion date:
December 1, 2025
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487507
