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OpenTrials
Completed

NCT Number: NCT06252701

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.

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Key information

About this study

There is a need for additional treatment or augmentation strategies for people who have depression. Epidemiological and observational studies show that an increased consumption of ultra-processed food (UPF) is associated with an increased risk of developing depression. This study will test the hypothesis that that reducing UPF intake from the diets of patients with major depressive disorder who eat a large percentage of UPF is a feasible and acceptable intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 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

Treatment and study plan

Reduction of Ultra-processed foods

Behavioral

Reduction of Ultra-processed foods for four weeks.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 4 weeks and 9 weeks

    Percent of enrolled of participants who have reduced their ultra-processed food intake

  2. Acceptability of the intervention

    Time frame: 4 weeks and 9 weeks

    Participant mean rating of ease of completing the intervention. The score range is 0-10 with 0 being very difficult to 10 being very easy.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Assessing the Feasibility and Acceptability of the Reduction of Ultra-processed Foods From the Diets of a Subset of Patients With Depression - A Pilot Open Label Crossover Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Nov 21, 2025

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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