DepressionNCT06242665
You Are What You Eat: Food as a Risk Factor and a Treatment for Depression
A study testing Low UPF Meals (Study Provided), Low UPF Nutritional Guidance and Low UPF Snacks (Study Provided) in people with Depression, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Low UPF Meals (Study Provided), Low UPF Nutritional Guidance and Low UPF Snacks (Study Provided)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
Read the 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
- Being tested
- Low UPF Meals (Study Provided), Low UPF Nutritional Guidance, Low UPF Snacks (Study Provided)
- Keywords
- Depression, Blood Glucose, Ultra-Processed Foods
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low UPF Meals (Study Provided)Other
Meals provided through delivery service
Low UPF Nutritional GuidanceOther
Self-guided instructions from study team.
Low UPF Snacks (Study Provided)Other
Low UPF snacks provided to participant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low UPF Nutritional Guidance; Other: Low UPF Snacks (Study Provided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed during dietary adherence period for 2 weeks
Secondary outcomes (5)
Blood Glucose Level
Assessed using a continuous blood glucose monitor
Measured: Assessed during dietary adherence period for 2 weeks
Sleep Quality
Assessed using a Fitbit
Measured: Assessed during dietary adherence period for 2 weeks
Metabolic Equivalent of Task (METs)
A measure of physical activity engagement assessed using a Fitbit
Measured: Assessed during dietary adherence period for 2 weeks
Feasibility of the Interventions
Assessed in a qualitative interview at Visit 3
Measured: Assessed post-dietary change during in-lab Visit 3 (1 day)
Accessibility of the Interventions
Assessed in a qualitative interview at Visit 3
Measured: Assessed post-dietary change during in-lab Visit 3 (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start9 Dec 2023
- Primary completion28 Jul 2024
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-method, mixed-design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Gearhardt, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242665
- Sponsor's protocol ID
- HUM00231527
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This research will generate demographic, heart rate, ecological momentary assessment, continuous glucose monitoring, self-report and anthropometric data. The data will be stored as SPSS or SAS files. Meta data will also be included in the selected repositories. The metadata will include the data dictionaries, which describe the generation of all variables. The deidentified data will be made available within one year of completion of the study at the University of Michigan's data repository - Deep Blue.
Publications
Worth IA, Furman CR, Li KR, Sonneville KR, Gearhardt AN. Examining the effects of two dietary intervention approaches on disordered eating-related thoughts and behaviors in adults with moderate to moderately severe depressive symptoms. J Eat Disord. 2026 May 23;14(1):171. doi: 10.1186/s40337-026-01640-8.
PubMed 42177608
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You Are What You Eat: Food as a Risk Factor and a Treatment for Depression
- ClinicalTrials.gov ID
- NCT06242665
- Acronym / sponsor ID
- HUM00231527
- Conditions
- Depression
- Keywords
- Depression, Blood Glucose, Ultra-Processed Foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multi-method, mixed-design
| Arm | Type | Receives |
|---|---|---|
| Meal Delivery | Experimental | Other: Low UPF Meals (Study Provided), Other: Low UPF Nutritional GuidanceDietary 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. |
| Nutritional Guidance | Experimental | Other: Low UPF Nutritional Guidance, Other: Low UPF Snacks (Study Provided)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low UPF Meals (Study Provided)Meals provided through delivery service | Other | Meal Delivery |
| Low UPF Nutritional GuidanceSelf-guided instructions from study team. | Other | Meal Delivery, Nutritional Guidance |
| Low UPF Snacks (Study Provided)Low UPF snacks provided to participant | Other | Nutritional Guidance |
Primary outcome
Low mood symptoms
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.
5 secondary outcomes
Blood Glucose Level
Time frame: Assessed during dietary adherence period for 2 weeks
Sleep Quality
Time frame: Assessed during dietary adherence period for 2 weeks
Metabolic Equivalent of Task (METs)
Time frame: Assessed during dietary adherence period for 2 weeks
Feasibility of the Interventions
Time frame: Assessed post-dietary change during in-lab Visit 3 (1 day)
Accessibility of the Interventions
Time frame: Assessed post-dietary change during in-lab Visit 3 (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 42177608Worth IA, Furman CR, Li KR, Sonneville KR, Gearhardt AN. Examining the effects of two dietary intervention approaches on disordered eating-related thoughts and behaviors in adults with moderate to moderately severe depressive symptoms. J Eat Disord. 2026 May 23;14(1):171. doi: 10.1186/s40337-026-01640-8.
- Individual participant dataSharing planned: Yes. This research will generate demographic, heart rate, ecological momentary assessment, continuous glucose monitoring, self-report and anthropometric data. The data will be stored as SPSS or SAS files. Meta data will also be included in the selected repositories. The metadata will include the data dictionaries, which describe the generation of all variables. The deidentified data will be made available within one year of completion of the study at the University of Michigan's data repository - Deep Blue.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low UPF Meals (Study Provided), Low UPF Nutritional Guidance and Low UPF Snacks (Study Provided) in people with Depression, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low mood symptoms (time frame: Assessed during dietary adherence period for 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.