Diet and Depression

University of California San Francisco (UCSF)

Status: Completed

Conditions: Major Depressive Disorder; Weight Gain; Obesity; Depression; Metabolic Syndrome

Treatments: Behavioral: Reduction of Ultra-processed foods

Study type: Interventional

Funder types: Other

Identifiers

NCT06252701

23-39884

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Intervention diet then regular diet

Experimental group

Description:

4 weeks eating a diet low in ultra-processed foods in diet followed by 4 weeks of eating the participant's regular diet.

Treatment:

Behavioral: Reduction of Ultra-processed foods

Regular diet then intervention diet

Experimental group

Description:

4 weeks of eating the participant's regular diet followed by 4 weeks of eating a diet low in ultra-processed foods.

Treatment:

Behavioral: Reduction of Ultra-processed foods