NCT06935097

Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.

Detailed description

Primary Objectives: To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68: * Enrollment (completion of 25 patient accrual within 2 years) * Retention (completion of the study through the 6-month time point, with ≥80% defined as successful) * Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful). Secondary Objectives: To determine changes due to the Mediterranean diet intervention in the following measures: * Mediterranean diet score (define using MEPA I calculated using VioScreen data) * Weight/BMI * QoL (EQ-5D-5L) * Physical activity (IPAS) * Non-invasive biomarkers * Gut microbiome * Metabolomics To determine fidelity of intervention,62 including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean diet-based Intervention	Through existing collaboration with the Harris Health system's innovative food pharmacy, participants will be provided fresh fruit, vegetables and other foods every other week during the study. Participants will receive olive oil and walnuts during the 8 week intervention (consistent with the PREDIMED6 intervention) to supplement their (and their families') diet during the 8-week intervention (while personalized education about diet, food choices and preparation is still occurring).

Timeline

• Start date: 2025-10-24
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2025-04-20
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States