Diet and Depression

NCT06252701 | Completed

• 1 other identifier: 23-39884
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder; Weight Gain; Obesity; Metabolic Syndrome

Keywords

Ultra-processed Food; Depression; Diet

Outcome Measures

Primary Outcomes (2)

• Feasibility of the intervention

  Percent of enrolled of participants who have reduced their ultra-processed food intake

  4 weeks and 9 weeks

• Acceptability of the intervention

  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

Study Arms (2)

Intervention diet then regular diet

EXPERIMENTAL

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

Regular diet then intervention diet

EXPERIMENTAL

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

Interventions

Reduction of Ultra-processed foods BEHAVIORAL

Reduction of Ultra-processed foods for four weeks.

Intervention diet then regular diet; Regular diet then intervention diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

Related Publications (7)

• Gomez-Donoso C, Sanchez-Villegas A, Martinez-Gonzalez MA, Gea A, Mendonca RD, Lahortiga-Ramos F, Bes-Rastrollo M. Ultra-processed food consumption and the incidence of depression in a Mediterranean cohort: the SUN Project. Eur J Nutr. 2020 Apr;59(3):1093-1103. doi: 10.1007/s00394-019-01970-1. Epub 2019 May 4.

  PMID: 31055621 BACKGROUND

• Adjibade M, Julia C, Alles B, Touvier M, Lemogne C, Srour B, Hercberg S, Galan P, Assmann KE, Kesse-Guyot E. Prospective association between ultra-processed food consumption and incident depressive symptoms in the French NutriNet-Sante cohort. BMC Med. 2019 Apr 15;17(1):78. doi: 10.1186/s12916-019-1312-y.

  PMID: 30982472 BACKGROUND

• Lane MM, Gamage E, Travica N, Dissanayaka T, Ashtree DN, Gauci S, Lotfaliany M, O'Neil A, Jacka FN, Marx W. Ultra-Processed Food Consumption and Mental Health: A Systematic Review and Meta-Analysis of Observational Studies. Nutrients. 2022 Jun 21;14(13):2568. doi: 10.3390/nu14132568.

  PMID: 35807749 BACKGROUND

• Hecht EM, Rabil A, Martinez Steele E, Abrams GA, Ware D, Landy DC, Hennekens CH. Cross-sectional examination of ultra-processed food consumption and adverse mental health symptoms. Public Health Nutr. 2022 Nov;25(11):3225-3234. doi: 10.1017/S1368980022001586. Epub 2022 Jul 28.

  PMID: 35899785 BACKGROUND

• Zheng L, Sun J, Yu X, Zhang D. Ultra-Processed Food Is Positively Associated With Depressive Symptoms Among United States Adults. Front Nutr. 2020 Dec 15;7:600449. doi: 10.3389/fnut.2020.600449. eCollection 2020.

  PMID: 33385006 BACKGROUND

• Pagliai G, Dinu M, Madarena MP, Bonaccio M, Iacoviello L, Sofi F. Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Br J Nutr. 2021 Feb 14;125(3):308-318. doi: 10.1017/S0007114520002688. Epub 2020 Aug 14.

  PMID: 32792031 BACKGROUND

• Mazloomi SN, Talebi S, Mehrabani S, Bagheri R, Ghavami A, Zarpoosh M, Mohammadi H, Wong A, Nordvall M, Kermani MAH, Moradi S. The association of ultra-processed food consumption with adult mental health disorders: a systematic review and dose-response meta-analysis of 260,385 participants. Nutr Neurosci. 2023 Oct;26(10):913-931. doi: 10.1080/1028415X.2022.2110188. Epub 2022 Sep 12.

  PMID: 36094005 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Weight Gain; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• D. Nyasha Chagwedera, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Andrew Krystal, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot open label crossover trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: June 18, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)