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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of the intervention
时间窗: 4 weeks and 9 weeks
Percent of enrolled of participants who have reduced their ultra-processed food intake
Acceptability of the intervention
时间窗: 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.
次要结局
未报告次要终点