Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by D. Nyasha Chagwedera, MD, PhDAndrew Krystal, MD, MS
Headshot of Andrew Krystal
Andrew Krystal

Description

Summary

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.

Official 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.

Details

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.

Keywords

Depression, Major Depressive Disorder, Weight Gain, Obesity, Metabolic Syndrome, Ultra-processed Food, Diet, Depressive Disorder, Reduction of Ultra-processed foods

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF accepting new patients
    San Francisco California 94107 United States

Lead Scientists at UCSF

  • D. Nyasha Chagwedera, MD, PhD
  • Andrew Krystal, MD, MS
    Dr. Krystal is the Ray and Dagmar Dolby Distinguished Professor in the Departments of Psychiatry and Neurology, Vice-Chair for Research in the Department of Psychiatry, Director of the Dolby Family Center for Mood Disorders, Director of the UCSF Interventional Psychiatry Program and Co-Director of the TMS & Neuromodulation Clinic.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06252701
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated