Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
A pilot open label crossover trial
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention diet then regular diet
4 weeks eating a diet low in ultra-processed foods in diet followed by 4 weeks of eating the participant's regular diet.
  • Behavioral: Reduction of Ultra-processed foods
    Reduction of Ultra-processed foods for four weeks.
Experimental
Regular diet then intervention diet
4 weeks of eating the participant's regular diet followed by 4 weeks of eating a diet low in ultra-processed foods.
  • Behavioral: Reduction of Ultra-processed foods
    Reduction of Ultra-processed foods for four weeks.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

D. Nyasha Chagwedera, MD, PhD
415-514-0444
dietmoodstudy@ucsf.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.