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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction of Ultra-processed foods | Behavioral | Reduction of Ultra-processed foods for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Nyasha Chagwedera, MD, PhD | University of California, San Francisco | Principal Investigator |
| Andrew Krystal, MD, MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31055621 | Background | 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. | |
| 30982472 | Background |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D015430 | Weight Gain |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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A pilot open label crossover trial
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| 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. |
| 35807749 | 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. |
| 35899785 | 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. |
| 33385006 | 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. |
| 32792031 | 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. |
| 36094005 | 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. |
| D001523 |
| Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |