Diet and Depression

Not Applicable

Recruiting

• Conditions: Weight Gain; Metabolic Syndrome; Major Depressive Disorder; Depression; Obesity
• Interventions: Behavioral: Reduction of Ultra-processed foods

• Registration Number: NCT06252701
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-12
• Study Start: 2024-06-18
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Regular diet then intervention diet	Reduction of Ultra-processed foods	4 weeks of eating the participant's regular diet followed by 4 weeks of eating a diet low in ultra-processed foods.
Intervention diet then regular diet	Reduction of Ultra-processed foods	4 weeks eating a diet low in ultra-processed foods in diet followed by 4 weeks of eating the participant's regular diet.

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	4 weeks and 9 weeks	Percent of enrolled of participants who have reduced their ultra-processed food intake
Acceptability of the intervention	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States