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OpenTrials
Enrolling by Invitation

NCT Number: NCT06935097

Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lyndon B Johnson Hospital

Houston, Texas, 77026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet-based Intervention

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).

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 20, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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