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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
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.
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.
University of Miami
Miami, Florida, United States
RECRUITINGProportion of patients consuming Mediterranean diet
Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.
Time frame: Up to 2 weeks
Change in fasting insulin
Measured in milliliters
Time frame: Baseline to 2 weeks
Change in high-sensitivity c-reactive protein
Measured in milligrams per liter
Time frame: Baseline to 2 weeks
Change in fasting glucose
Measured in milligrams per deciliter
Time frame: Baseline to 2 weeks
Change in blood pressure
Measured in millimeters of mercury
Time frame: Baseline to 2 weeks
Dietary behavior as measured by diet records questionnaire
Measured in percentage of meals consumed by the participants
Time frame: Up to 2 weeks
Number of treatment related adverse events
Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.
Time frame: Up to 2 weeks
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