Diet and Depression
This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF.
Conditions:
🦠 Depression 🦠 Major Depressive Disorder 🦠 Weight Gain 🦠 Obesity 🦠 Metabolic Syndrome
🗓️ Study Start (Actual) June 2024
🗓️ Primary Completion (Estimated) October 2026
✅ Study Completion (Estimated) October 2026
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18-70 year olds (inclusive), all race/ethnic groups
    • * Willing to not change psychotropic medication or psychotherapy regimen during the study
    • * Willing and able to come to UCSF for in person visits two times
    • * Ability to speak and read English and answer participant surveys

    Exclusion Criteria:

    • * Psychiatric hospitalization in past 3 months
    • * Active suicidal ideation with intent and plan or scoring a 3 or higher on the Columbia suicide severity rating scale (C-SSRS)
    • * In a current severe mood state when entering the study that would prohibit compliance with study visits or dietary program
    • * Known GI abnormalities or known GI medical problems (diarrhea, chronic intestinal disease, toxic megacolon, ileum) or known swallowing or chewing disorders or issues
    • * Anticipating or planning any major changes in physical activity or sleep during the study
    • * Pregnant or planning to be pregnant during the study
    • * Breastfeeding or planning to breastfeed during the study
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 January 2024
  • First Submitted that Met QC Criteria 8 February 2024
  • First Posted 12 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024