Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

NCT ID: NCT06935097

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2029-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention with Mediterranean Diet

Twenty-five (25) self-identified Black and/or Hispanic men with newly diagnosed (within 6 months) localized PCa or who have been managed on active surveillance for less than 5 years will be enrolled along with their spouses (if applicable).

Group Type: EXPERIMENTAL

Mediterranean diet-based Intervention

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Gregg, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Lyndon B Johnson Hospital

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2025-02780

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0331

Identifier Type: -

Identifier Source: org_study_id