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

NCT ID: NCT06242665

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-09
• Study Completion Date: 2025-01-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low UPF Meals (Study Provided)

Intervention Type: OTHER

Meals provided through delivery service

Low UPF Nutritional Guidance

Intervention Type: OTHER

Self-guided instructions from study team.

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.

Group Type: EXPERIMENTAL

Low UPF Nutritional Guidance

Intervention Type: OTHER

Self-guided instructions from study team.

Low UPF Snacks (Study Provided)

Intervention Type: OTHER

Low UPF snacks provided to participant

Interventions

Low UPF Meals (Study Provided)

Meals provided through delivery service

Intervention Type: OTHER

Low UPF Nutritional Guidance

Self-guided instructions from study team.

Intervention Type: OTHER

Low UPF Snacks (Study Provided)

Low UPF snacks provided to participant

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ashley Gearhardt

Professor of Psychology, College of Literature, Science, and the Arts

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00231527

Identifier Type: -

Identifier Source: org_study_id