Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
Case Comprehensive Cancer Center
Summary
The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer. The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.
Description
Primary Objective -Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism Secondary Objectives * Evaluate the impact of Med-t-Diets on host metabolism * Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets * Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Males ≥18 years old * High suspicion of prostate cancer (PCa) per urologist's clinical evaluation * BMI \>18.5 * No prior PCa diagnosis or hormonal therapy (-ies) * Ability to read, write, speak, and understand English * Ability to provide informed consent * Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive * Willingness to consume provided dietary interventions * Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥9 g/dL (transfusions…
Interventions
- OtherLower-Carbohydrate Med-t-Diet
Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 45% fats, 35% carbs, 20% protein
- OtherLow-Fat Med-t-Diet
Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 70% carbs, 20% protein, 10% fat
Location
- Case Comprehensive Cancer Center, Cleveland Clinic FoundationCleveland, Ohio