Clinical trial NCT06252701: Diet and Depression
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Major Depressive Disorder
Weight Gain
Obesity
Metabolic Syndrome
Keywords: Ultra-processed Food
Depression
Diet
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A pilot open label crossover trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: 4 weeks and 9 weeks
measure: Acceptability of the intervention
timeFrame: 4 weeks and 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: D. Nyasha Chagwedera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Andrew Krystal, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
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.