Reducing ultra-processed foods to help with depression
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.
This study is testing if cutting down on ultra-processed foods can help people with major depression feel better while they continue their usual medication and therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06252701 on ClinicalTrials.gov |
What this trial studies
This pilot open label crossover trial aims to assess the feasibility and acceptability of reducing ultra-processed foods (UPF) in the diets of patients with major depressive disorder who consume a high percentage of UPF. The study is based on the hypothesis that a reduction in UPF intake may positively impact depressive symptoms. Participants will be required to maintain their current psychotropic medication and psychotherapy regimen while attending in-person visits at UCSF. The study will evaluate the intervention's practicality and participants' willingness to adhere to dietary changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with major depressive disorder who consume a significant amount of ultra-processed foods.
Not a fit: Patients with recent psychiatric hospitalization, severe mood states, or significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel dietary approach to augmenting treatment for patients with major depressive disorder.
How similar studies have performed: While the relationship between diet and depression has been explored, this specific approach of reducing UPF in a personalized manner is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: D. Nyasha Chagwedera, MD, PhD — University of California, San Francisco
- Study coordinator: D. Nyasha Chagwedera, MD, PhD
- Email: dietmoodstudy@ucsf.edu
- Phone: 415-514-0444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.