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

NCT06242665 | Completed

• 1 other identifier: HUM00231527
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Depression; Blood Glucose; Ultra-Processed Foods

Outcome Measures

Primary Outcomes (1)

• Low mood symptoms

  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.

  Assessed during dietary adherence period for 2 weeks

Secondary Outcomes (5)

• Blood Glucose Level

  Assessed during dietary adherence period for 2 weeks

• Sleep Quality

  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)

• Accessibility of the Interventions

  Assessed post-dietary change during in-lab Visit 3 (1 day)

Study Arms (2)

Meal Delivery

EXPERIMENTAL

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.

Other: Low UPF Meals (Study Provided); Other: Low UPF Nutritional Guidance

Nutritional Guidance

EXPERIMENTAL

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.

Other: Low UPF Nutritional Guidance; Other: Low UPF Snacks (Study Provided)

Interventions

Low UPF Meals (Study Provided) OTHER

Meals provided through delivery service

Meal Delivery

Low UPF Nutritional Guidance OTHER

Self-guided instructions from study team.

Meal Delivery; Nutritional Guidance

Low UPF Snacks (Study Provided) OTHER

Low UPF snacks provided to participant

Nutritional Guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology, College of Literature, Science, and the Arts

Model Details: Multi-method, mixed-design

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 5, 2024
• Study Start: December 9, 2023
• Primary Completion: July 28, 2024
• Study Completion: January 22, 2025
• Last Updated: February 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year and ending 7 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access data to achieve aims outlined in the approved proposal. Proposals should be directed to agearhar@umich.edu to gain access. Data requestors will need to sign a data access agreement.

Locations

US (1)