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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility of the intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention diet then regular diet
4 weeks eating a diet low in ultra-processed foods in diet followed by 4 weeks of eating the participant's regular diet.
Intervention: Reduction of Ultra-processed foods (Behavioral)
Regular diet then intervention diet
4 weeks of eating the participant's regular diet followed by 4 weeks of eating a diet low in ultra-processed foods.
Intervention: Reduction of Ultra-processed foods (Behavioral)
Outcomes
Primary Outcomes
Feasibility of the intervention
Time Frame: 4 weeks and 9 weeks
Percent of enrolled of participants who have reduced their ultra-processed food intake
Acceptability of the intervention
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported