University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06242665
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Meals provided through delivery service
Self-guided instructions from study team.
Low UPF snacks provided to participant
Time frame: 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.
Time frame: Assessed during dietary adherence period for 2 weeks
Assessed using a continuous blood glucose monitor
Time frame: Assessed during dietary adherence period for 2 weeks
Assessed using a Fitbit
Time frame: Assessed during dietary adherence period for 2 weeks
A measure of physical activity engagement assessed using a Fitbit
Time frame: Assessed post-dietary change during in-lab Visit 3 (1 day)
Assessed in a qualitative interview at Visit 3
Time frame: Assessed post-dietary change during in-lab Visit 3 (1 day)
Assessed in a qualitative interview at Visit 3
University of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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