Diet and Depression

Obesity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252701
• Other study ID #: 23-39884
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: October 2026

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: D. Nyasha Chagwedera, MD, PhD
• Phone: 415-514-0444
• Email: dietmoodstudy[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Reduction of Ultra-processed foods
Reduction of Ultra-processed foods for four weeks.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	Percent of enrolled of participants who have reduced their ultra-processed food intake	4 weeks and 9 weeks
Primary	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