You Are What You Eat: Food as a Risk Factor and a Treatment for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Low mood symptoms
研究概览
简要总结
This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods (MPF) to reduce depression. The following aims and hypotheses are tested:
Aim 1: To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression.
H1: It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression.
Aim 2: To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition.
H2: Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition (nutrition guidance only).
详细描述
The study will include a combination of in-person, at-home, and virtual activities over the course of ~21 days (contingent on scheduling, this duration may vary and particularly between in-person visits #1 and #2). Participants complete three in-lab visits, each followed by a week of remote data tasks (e.g., ecological momentary assessment, continuous glucose monitoring, and physical activity and sleep tracking (Fitbit)).
During in-lab visit #1, participants will complete questionnaires and interviews, have a continuous glucose monitor inserted, and will have body composition measurements taken (height, weight, Inbody scan). Participants will complete the remote tasks for the following week while eating their typical diet (i.e., baseline period).
During in-lab visit #2, participants will complete questionnaires, interviews, and body composition measurements (height, weight, Inbody scan). Participants are randomly assigned to a meal delivery (will receive two weeks of low UPF meals and nutrition guidance) or control (will receive some snacks and nutrition guidance) condition (i.e., dietary intervention period). Participants will complete the remote tasks for the following two weeks.
During in-lab visit #3, participants will complete questionnaires, interviews, and body composition measurements (height, weight, InBody scan).
Participants are contacted 1- and 6-months later to complete a short follow-up survey and provide information about their current diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years of age
- •Must own an Android or iPhone smartphone
- •Must be able to access phone one every 90 minutes
- •Able to attend consent call over zoom or phone
- •Endorsement of a PHQ-8 score of at least 10 assessed at consent
- •Endorsement of a PHQ-8 score of at least 8 assessed 24 hours prior to Visit 1
- •Endorse daily intake of at least UPF foods
- •Willing to come to three in-lab visits
- •Willing to follow dietary guidelines
- •Must be able to speak, write, and read English fluently
排除标准
- •Regular smoking of cigarettes or vaping of nicotine
- •History of medication that impact reward, eating, or indicate severe mental health conditions (e.g., Lithium)
- •The following medical conditions; Diabetes Type I, Diabetes Type II, Prediabetes, Bipolar Disorder, Schizophrenia, Psychotic Disorder, Depression with psychotic symptoms, Borderline Personality Disorder, Hypoglycemia, Substance use disorder (e.g., alcohol use disorder, opioid use disorder, cannabis use disorder), Obsessive compulsive disorder, and Post-traumatic stress disorder
- •Endorsement of a suicide attempt or having been hospitalized for psychiatric reasons in the last year
- •A diagnosis of a restrictive eating disorder (anorexia nervosa, bulimia nervosa, purging disorder) within the last 5 years
- •History of disorders that impact eating (e.g., cancer, irritable bowel syndrome, inflammatory bowel disease, hypothyroidism).
- •Current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth
- •Frequent (i.e., weekly) night shift work or irregular shifts and for abnormal sleep patterns (i.e., wake up time after 11am)
研究组 & 干预措施
Meal Delivery
Dietary change (low ultra-processed meal delivery) and nutrition guidance to follow a low UPF diet.
All participants complete a series of three in-lab visits with remote data collection:
Visit 1 and the following week comprise the baseline assessment period.
Visit 2 and the following 2 weeks comprise the dietary intervention period. Meal delivery and nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet.
Visit 3 comprises post-intervention assessment All participants will complete remote assessments at 1 month and 6 month follow-ups.
干预措施: Low UPF Meals (Study Provided) (Other)
Nutritional Guidance
Dietary change (nutritional guidance)
Visit 1 and the following week comprise the baseline assessment period.
Visit 2 and the following week comprise the dietary intervention period. Nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Participants are delivered a box of snacks consistent with a low UPF diet.
Visit 3 comprises post-intervention assessment. All participants will complete remote assessments at 1 month and 6 month follow ups.
干预措施: Low UPF Nutritional Guidance (Other)
Nutritional Guidance
Dietary change (nutritional guidance)
Visit 1 and the following week comprise the baseline assessment period.
Visit 2 and the following week comprise the dietary intervention period. Nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Participants are delivered a box of snacks consistent with a low UPF diet.
Visit 3 comprises post-intervention assessment. All participants will complete remote assessments at 1 month and 6 month follow ups.
干预措施: Low UPF Snacks (Study Provided) (Other)
Meal Delivery
Dietary change (low ultra-processed meal delivery) and nutrition guidance to follow a low UPF diet.
All participants complete a series of three in-lab visits with remote data collection:
Visit 1 and the following week comprise the baseline assessment period.
Visit 2 and the following 2 weeks comprise the dietary intervention period. Meal delivery and nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet.
Visit 3 comprises post-intervention assessment All participants will complete remote assessments at 1 month and 6 month follow-ups.
干预措施: Low UPF Nutritional Guidance (Other)
结局指标
主要结局
Low mood symptoms
时间窗: Assessed during dietary adherence period for 2 weeks
Depression symptoms (e.g., anhedonia, low energy) will be assessed with the Patient Health Questionnaire (PHQ-8) using ecological momentary assessment and at each study visit. The PHQ-8 scores 8 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-8 scores indicate greater depression symptoms.
次要结局
- Sleep Quality(Assessed during dietary adherence period for 2 weeks)
- Accessibility of the Interventions(Assessed post-dietary change during in-lab Visit 3 (1 day))
- Blood Glucose Level(Assessed during dietary adherence period for 2 weeks)
- Metabolic Equivalent of Task (METs)(Assessed during dietary adherence period for 2 weeks)
- Feasibility of the Interventions(Assessed post-dietary change during in-lab Visit 3 (1 day))
研究者
Ashley Gearhardt
Professor of Psychology, College of Literature, Science, and the Arts
University of Michigan