Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean diet-based Intervention.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment.
- Diagnosis within 12 months prior to enrollment OR
- Currently managed on active surveillance, with initial biopsy being <5 years from date of enrollment
- Self-identified Hispanic and/or Black/African American
- Patient at LBJ Hospital
Exclusion criteria
- Special dietary requirements such that patient is unwilling to attempt dietary change
- Unwillingness to participate in study activities
- Inability to keep appointments
- Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Lyndon B Johnson Hospital — Houston
Identifiers
NCT: NCT06935097 · 2025-0331 · NCI-2025-02780