NCT06242665

You Are What You Eat: Food As a Risk Factor and a Treatment for Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	Low UPF Meals (Study Provided)	Meals provided through delivery service
OTHER	Low UPF Nutritional Guidance	Self-guided instructions from study team.
OTHER	Low UPF Snacks (Study Provided)	Low UPF snacks provided to participant

Timeline

• Start date: 2023-12-09
• Primary completion: 2024-07-28
• Completion: 2025-01-22
• First posted: 2024-02-05
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States