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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242665
• Other study ID #: HUM00231527
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Ashley Gearhardt, PhD
• Phone: 734-647-3920
• Email: agearhar[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Low UPF Meals (Study Provided)
Meals provided through delivery service
• Low UPF Nutritional Guidance
Self-guided instructions from study team.
• Low UPF Snacks (Study Provided)
Low UPF snacks provided to participant

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Glucose Level	Assessed using a continuous blood glucose monitor	Assessed during dietary adherence period for 2 weeks
Secondary	Sleep Quality	Assessed using a Fitbit	Assessed during dietary adherence period for 2 weeks
Secondary	Metabolic Equivalent of Task (METs)	A measure of physical activity engagement assessed using a Fitbit	Assessed during dietary adherence period for 2 weeks
Secondary	Feasibility of the Interventions	Assessed in a qualitative interview at Visit 3	Assessed post-dietary change during in-lab Visit 3 (1 day)
Secondary	Accessibility of the Interventions	Assessed in a qualitative interview at Visit 3	Assessed post-dietary change during in-lab Visit 3 (1 day)