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Behavioral Intervention
Mediterranean Diets for Prostate Cancer
N/A
Waitlist Available
Led By Nima Sharifi, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care
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
Must not have
Previous history of pelvic radiation
Receiving active medical treatment for Type I or Type II diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if patients with prostate cancer who follow a Mediterranean-style diet before surgery have different insulin levels and other blood and tissue measurements compared to those who do not follow the diet. This
Who is the study for?
This trial is for men diagnosed with prostate cancer who are scheduled to undergo robotic-assisted radical prostatectomy. Participants should be willing to follow a specific Mediterranean-style diet before surgery.
What is being tested?
The study is testing the effects of two types of Mediterranean diets—one low in fat and the other lower in carbohydrates—on fasting insulin levels and other measurable values from blood and tissue samples taken during prostate cancer surgery.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include changes in weight, digestive discomfort or alterations in energy levels due to diet modification.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man between 18 and 80 years old planning to have surgery for prostate cancer.
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My blood counts and organ functions are within the required ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy to my pelvic area before.
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I am currently being treated for diabetes.
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I have had weight loss surgery.
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My blood pressure is over 140/80, even with medication.
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I have been treated for prostate cancer before.
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I am unable to make my own medical decisions.
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I have a history of gout.
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My gallbladder has been removed or is scheduled for removal.
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I have had diabetic ketoacidosis before.
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I have lost or gained more than 5% of my body weight in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients consuming Mediterranean diet
Secondary study objectives
Change in blood pressure
Change in fasting glucose
Change in fasting insulin
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lower Carbohydrate Mediterranean Diet GroupExperimental Treatment1 Intervention
Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.
Group II: Low Fat Diet GroupExperimental Treatment1 Intervention
Participants in this group will receive a low fat Mediterranean diet for 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lower carbohydrate diet
2017
N/A
~63660
Low fat diet
2008
N/A
~400
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
950 Previous Clinical Trials
428,335 Total Patients Enrolled
19 Trials studying Prostate Cancer
4,277 Patients Enrolled for Prostate Cancer
Nima Sharifi, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer