Diet and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2025-06-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Depression Major Depressive Disorder Weight Gain Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A pilot open label crossover trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Reduction of Ultra-processed foods

Intervention Type BEHAVIORAL

Reduction of Ultra-processed foods for four weeks.

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.

Group Type EXPERIMENTAL

Reduction of Ultra-processed foods

Intervention Type BEHAVIORAL

Reduction of Ultra-processed foods for four weeks.

Interventions

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Reduction of Ultra-processed foods

Reduction of Ultra-processed foods for four weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No