Diet and Depression

March 14, 2024 updated by: University of California, San Francisco

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Recruiting
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention
Time Frame: 4 weeks and 9 weeks
Percent of enrolled of participants who have reduced their ultra-processed food intake
4 weeks and 9 weeks
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.
4 weeks and 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Andrew Krystal, MD, MS, University of California, San Francisco
  • Principal Investigator: D. Nyasha Chagwedera, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-39884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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