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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Fat Diet Group | Experimental | Participants in this group will receive a low fat Mediterranean diet for 2 weeks. |
|
| Lower Carbohydrate Mediterranean Diet Group | Experimental | Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients consuming Mediterranean diet | Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting insulin | Measured in milliliters | Baseline to 2 weeks |
| Change in high-sensitivity c-reactive protein | Measured in milligrams per liter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nima Sharifi, MD | Contact | 305-243-1350 | nimasharifi@miami.edu | |
| Elena Cortizas, MS | Contact | 3052433593 | ecortizas@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nima Sharifi, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| 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. |
|
| Baseline to 2 weeks |
| Change in fasting glucose | Measured in milligrams per deciliter | Baseline to 2 weeks |
| Change in blood pressure | Measured in millimeters of mercury | Baseline to 2 weeks |
| Dietary behavior as measured by diet records questionnaire | Measured in percentage of meals consumed by the participants | 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. | Up to 2 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |