University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Elena Cortizas, MS
CONTACT
Nima Sharifi, MD
PRINCIPAL_INVESTIGATOR
Sanoj Punnen, MD
SUB_INVESTIGATOR
NCT Number: NCT06487507
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.
Interested in participating?
Request Info18 year–80 year
Male
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Elena Cortizas, MS
CONTACT
Nima Sharifi, MD
PRINCIPAL_INVESTIGATOR
Sanoj Punnen, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 2 weeks
Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.
Time frame: Baseline to 2 weeks
Measured in milliliters
Time frame: Baseline to 2 weeks
Measured in milligrams per liter
Time frame: Baseline to 2 weeks
Measured in milligrams per deciliter
Time frame: Baseline to 2 weeks
Measured in millimeters of mercury
Time frame: Up to 2 weeks
Measured in percentage of meals consumed by the participants
Time frame: Up to 2 weeks
Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.
Contact information is provided by the study sponsor or research team.
Elena Cortizas, MS
CONTACT
Nima Sharifi, MD
CONTACT
University of Miami
Other
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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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