Depression, Major Depressive Disorder, Metabolic Syndrome, Obesity, Weight Gain
Conditions
Keywords
Ultra-processed Food, Depression, Diet
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.
Interventions
BEHAVIORALReduction of Ultra-processed foods
Reduction of Ultra-processed foods for four weeks.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A pilot open label crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention | 4 weeks and 9 weeks | Percent of enrolled of participants who have reduced their ultra-processed food intake |
| Acceptability of the intervention | 4 weeks and 9 weeks | 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. |
Countries
United States
Outcome results
None listed