Depression - Major Depressive DisorderNCT07490782
Nutritional Intervention for College Students With Depression
A study testing Mediterranean Diet and Time-Restricted Eating in people with Depression - Major Depressive Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are: Nutritional content, meal timing, and sleep patterns in college students with depression Feasibility of nutritional interventions (Mediterranean Diet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Mediterranean Diet and Time-Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years and enrolled as a college student
- Symptoms of mild to moderate depression
- Receiving treatment for depression or willing to receive treatment during study participation
- Generally in good physical health
- On a stable dose of any medication affecting weight, metabolism, or mental health
Who cannot join
- Elevated risk for suicide
- Inability to participate safely, as determined by the study physician
- Lifetime diagnosis of bipolar disorder, schizophrenia, or post-traumatic stress disorder
- Current eating disorder (e.g., bulimia, anorexia nervosa, binge eating)
- Current alcohol or substance use disorder
- Shift work outside of class schedule in the past 30 days
- Pregnancy or lactation
- Treatment with an investigational drug for depression or participation in another study requiring modification of diet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Michael J McCarthy, 858-534-8070, mmccarthy@health.ucsd.edu
About this study
The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are:
- Nutritional content, meal timing, and sleep patterns in college students with depression
- Feasibility of nutritional interventions (Mediterranean Diet and Time-Restricted Eating + Mediterranean Diet) in college students with depression
Read more
Researchers will compare two groups - Mediterranean Diet (Med-Diet) and Time-Restricted Eating + Mediterranean Diet (TRE + Med-Diet) - to assess adherence to the dietary interventions and overall feasibility of the study procedures.
Participants will:
- Complete a 2-week baseline logging diet, sleep, activity, and mood
- Be randomized to Mediterranean Diet (Med-Diet) or Time-Restricted Eating + Med-Diet (TRE + Med-Diet)
- Participate in dietary counseling with a registered dietitian during the 8-week intervention
- Continue to log diet, wear an actigraphy device, and complete mood, sleep, and diet assessments throughout the intervention
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Mediterranean Diet, Time-Restricted Eating
- Keywords
- time-restricted eating, Mediterranean diet, nutritional intervention, feasibility
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Participants will receive ongoing dietary counseling, nutritional resources, and practical tips to support adoption of a Mediterranean-style dietary pattern emphasizing healthy fats (e.g., olive oil), whole grains, fruits, vegetables, and legumes, while limiting red meat and dairy products throughout the intervention period.
Time-Restricted EatingBehavioural
Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Not described Receives: Behavioral: Mediterranean Diet |
| Time-Restricted Eating + Mediterranean Diet | Experimental | Not described Receives: Behavioral: Mediterranean Diet; Behavioral: Time-Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset
Actigraphy determined sleep onset time (h:m)
Measured: From enrollment to the end of baseline (2 weeks)
Sleep offset
Actigraphy determined sleep offset time (h:m)
Measured: From enrollment to the end of baseline (2 weeks)
Sleep Duration
Formula: sleep offset - sleep onset (h:m). A larger number indicates a longer sleep duration.
Measured: From enrollment to the end of baseline (2 weeks)
M10
Average activity level from 10 hours of highest activity (counts/hour)
Measured: From enrollment to the end of baseline (2 weeks)
L5
Average activity level from 5 hours of lowest activity (counts/hour)
Measured: From enrollment to the end of baseline (2 weeks)
Relative Amplitude
Formula: Relative Amplitude =(M10-L5)/(M10+L5). A value near 1 indicates a strong, well-defined circadian rhythm (high activity during the day and very low activity at night), and a value near 0 indicates a fragmented or "flat" rhythm (little difference between your most active and least active periods).
Measured: From enrollment to the end of baseline (2 weeks)
Interdaily Stability
The ratio of the variance of the average 24-hour activity profile to the variance of the overall 24-hour data. Actigraphy is collected over 2 weeks and averaged to create a single, representative 24-hour profile. Interdaily Stability values range from 0 to 1, where 0 indicates a total lack of stability and 1 indicates perfect stability. Lower values suggest fragmented, weak, or disrupted circadian rhythms.
Measured: From enrollment to the end of baseline (2 weeks)
Caloric intake timing
Time of calorie consumption (h:m)
Measured: From enrollment to the end of baseline (2 weeks)
MEQ Score
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report assessment used to determine an individual's circadian preference (chronotype), ranging from morning-type to evening-type. Scores range from 16 to 86, with higher scores indicating morningness and lower scores indicating eveningness.
Measured: Baseline measure in week 2
PHQ9 Score
The PHQ-9 is a 9-item, self-report questionnaire used to screen for and measure the severity of depression in clinical trials. It covers the 9 diagnostic criteria for major depressive disorder based on the DSM-IV. Total scores range from 0 to 27, with higher scores indicating higher levels of depression.
Measured: Baseline measure in week 2
PDQ-D5 Score
The PDQ-D5 is a self-report questionnaire assessing subjective cognitive impairment. It includes five items covering four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. The total score is the sum of the five items, ranging from 0 to 20. Higher scores indicate greater perceived cognitive deficits, while lower scores indicate fewer problems.
Measured: Baseline measure in week 2
PSQI Score
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality and disturbances over a one-month interval. It measures seven components (quality, latency, duration, efficiency, disturbances, medication, dysfunction) to produce a global score from 0 to 21, where higher scores indicate poorer sleep quality.
Measured: Baseline measure in week 2
Recruitment Rate
Formula: Total participants enrolled / enrollment time window, with higher numbers indicating better recruitment.
Measured: From study initiation to end of recruitment period (approximately 16 months)
Retention Rate
Formula: (number of participants that complete the study / number of participants that enrolled) x 100, reported as percentage with higher numbers indicating higher retention.
Measured: From enrollment to study completion (approximately 19 months)
Missing Data Rate
The missing data rate is defined as the percentage of expected data points for primary outcomes (e.g., daily food logs, daily actigraphy wearing, and survey responses) that were not collected or were unusable at the final study visit. Calculation: (Number of missing data points / Total number of expected data points across all enrolled participants) × 100 reported as a percentage with higher values indicating more missing data. Note: This includes data missing due to participant withdrawal or non-response to specific survey items.
Measured: From baseline to end of study visit (weeks 1-12)
Change in Mediterranean Diet Adherence Screener (13-MEDAS) Score
Adherence to the Mediterranean Diet is assessed using the validated 13-item Mediterranean Diet Adherence Screener (13-MEDAS). The questionnaire evaluates the consumption frequency of Mediterranean dietary staples (e.g., olive oil, vegetables, fruits, nuts, fish, legumes) and frequency of unhealthy food choices (e.g., animal fats, sugar-sweetened beverages). Each item is scored 0 or 1. The total score ranges from 0 to 13, with higher scores indicating greater adherence.
Measured: Measured at baseline in week 2 and during intervention in week 10
Time-restricted eating adherence
Using the time of first and last caloric intake of the day, time-restricted eating adherence is calculated as the percentage of days where all food was consumed within the designated 10 h time window.
Measured: Measured throughout nutritional intervention (week 3-11)
Mediterranean Diet Intervention Acceptability
Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The Mediterranean diet changes were manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data for all participants reported. Higher values indicate diet content modifications were more manageable.
Measured: End of study (week 10-12)
Time-Restricted Eating Intervention Acceptability
Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The time restriction on calorie intake was manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data reported for Group 2 only (Mediterranean Diet + Time-Restricted Eating). Higher values indicate diet timing modifications were more manageable.
Measured: End of study (week 10-12)
Participant-Reported Global Impression of Change in Depression
A single-item assessment of the overall change in depression since study entry. Scale: 1 = Very Much Worse, 2 = Much Worse, 3 = Minimally Worse, 4 = No Change, 5 = Minimally Improved, 6 = Much Improved, 7 = Very Much Improved. Higher scores indicate greater improvement.
Measured: End of study (week 10-12)
Perceived Impact of Dietary Changes on Sleep
A single item ("The dietary changes made during the study had a positive impact on my sleep") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Measured: End of study (week 10-12)
Perceived Impact of Dietary Changes on Metabolic Health
A single item ("The dietary changes made during the study had a positive impact on my metabolic health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Measured: End of study (week 10-12)
Perceived Impact of Dietary Changes on Overall Health
A single item ("The dietary changes made during the study had a positive impact on my overall health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Measured: End of study (week 10-12)
Participant-Reported Intent for Long-term Dietary Maintenance
A single-item assessment of the participant's intention to continue the intervention diet after the study concludes ('I plan to maintain dietary changes from the study moving forward') will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a higher intent to maintain the dietary changes.
Measured: End of study (week 10-12)
Secondary outcomes (6)
Change in Sleep Duration
Sleep Duration = Sleep Offset - Sleep Onset (h:m). Change in Sleep Duration will be calculated with baseline (2 week period) and end of intervention (2 week period).
Measured: Baseline (week 1-2) and intervention (week 9-11)
Change in Relative Amplitude
Relative Amplitude =(M10-L5)/(M10+L5). A value near 1 indicates a strong, well-defined circadian rhythm (high activity during the day and very low activity at night), and a value near 0 indicates a fragmented or "flat" rhythm (little difference between your most active and least active periods). Change in Relative Amplitude will be calculated with baseline (2 week period) and end of intervention (2 week period).
Measured: Baseline (week 1-2) and intervention (week 9-11)
Change in Interdaily Stability
The ratio of the variance of the average 24-hour activity profile to the variance of the overall 24-hour data. Actigraphy is collected over 2 weeks and averaged to create a single, representative 24-hour profile. Interdaily Stability values range from 0 to 1, where 0 indicates a total lack of stability and 1 indicates perfect stability. Lower values suggest fragmented, weak, or disrupted circadian rhythms. Change in Interdaily Stability will be calculated with baseline (2 week period) and end of intervention (2 week period).
Measured: Baseline (weeks 1-2) and intervention (weeks 9-11)
Change in PHQ9
The PHQ-9 is a 9-item, self-report questionnaire used to screen for and measure the severity of depression in clinical trials. It covers the 9 diagnostic criteria for major depressive disorder based on the DSM-IV. Total scores range from 0 to 27, with higher scores indicating higher levels of depression. Change in PHQ9 will be calculated with baseline (week 2) and end of intervention (week 10).
Measured: Baseline (week 2) and intervention (week 10)
Change in PDQ-D5 Score
The PDQ-D5 is a self-report questionnaire assessing subjective cognitive impairment. It includes five items covering four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. The total score is the sum of the five items, ranging from 0 to 20. Higher scores indicate greater perceived cognitive deficits, while lower scores indicate fewer problems. Change in PDQ-D5 will be calculated with baseline (week 2) and end of intervention (week 10).
Measured: Baseline (week 2) and intervention (week 10)
Change in PSQI Score
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality and disturbances over a one-month interval. It measures seven components (quality, latency, duration, efficiency, disturbances, medication, dysfunction) to produce a global score from 0 to 21, where higher scores indicate poorer sleep quality. Change in PSQI will be calculated with baseline (week 2) and end of intervention (week 10).
Measured: Baseline (week 2) and intervention (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McCarthy, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490782
- Sponsor's protocol ID
- 813542
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention for College Students With Depression
- ClinicalTrials.gov ID
- NCT07490782
- Acronym / sponsor ID
- 813542
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- time-restricted eating, Mediterranean diet, nutritional intervention, feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are:
- Nutritional content, meal timing, and sleep patterns in college students with depression
- Feasibility of nutritional interventions (Mediterranean Diet and Time-Restricted Eating + Mediterranean Diet) in college students with depression
Researchers will compare two groups - Mediterranean Diet (Med-Diet) and Time-Restricted Eating + Mediterranean Diet (TRE + Med-Diet) - to assess adherence to the dietary interventions and overall feasibility of the study procedures.
Participants will:
- Complete a 2-week baseline logging diet, sleep, activity, and mood
- Be randomized to Mediterranean Diet (Med-Diet) or Time-Restricted Eating + Med-Diet (TRE + Med-Diet)
- Participate in dietary counseling with a registered dietitian during the 8-week intervention
- Continue to log diet, wear an actigraphy device, and complete mood, sleep, and diet assessments throughout the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Behavioral: Mediterranean Diet |
| Time-Restricted Eating + Mediterranean Diet | Experimental | Behavioral: Mediterranean Diet, Behavioral: Time-Restricted Eating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and enrolled as a college student
- Symptoms of mild to moderate depression
- Receiving treatment for depression or willing to receive treatment during study participation
- Generally in good physical health
- On a stable dose of any medication affecting weight, metabolism, or mental health
Key exclusion criteria (8 listed)
- Elevated risk for suicide
- Inability to participate safely, as determined by the study physician
- Lifetime diagnosis of bipolar disorder, schizophrenia, or post-traumatic stress disorder
- Current eating disorder (e.g., bulimia, anorexia nervosa, binge eating)
- Current alcohol or substance use disorder
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 |
|---|---|---|
| Mediterranean DietParticipants will receive ongoing dietary counseling, nutritional resources, and practical tips to support adoption of a Mediterranean-style dietary pattern emphasizing healthy fats (e.g., olive oil), whole grains, fruits, vegetables, and legumes, while limiting red meat and dairy products throughout the intervention period. | Behavioural | Mediterranean Diet, Time-Restricted Eating + Mediterranean Diet |
| Time-Restricted EatingParticipants will receive guidance to restrict daily food intake to a consistent 10-hour eating window. | Behavioural | Time-Restricted Eating + Mediterranean Diet |
Primary outcome
Sleep onset
Time frame: From enrollment to the end of baseline (2 weeks)
Actigraphy determined sleep onset time (h:m)
Sleep offset
Time frame: From enrollment to the end of baseline (2 weeks)
Actigraphy determined sleep offset time (h:m)
Sleep Duration
Time frame: From enrollment to the end of baseline (2 weeks)
Formula: sleep offset - sleep onset (h:m). A larger number indicates a longer sleep duration.
M10
Time frame: From enrollment to the end of baseline (2 weeks)
Average activity level from 10 hours of highest activity (counts/hour)
L5
Time frame: From enrollment to the end of baseline (2 weeks)
Average activity level from 5 hours of lowest activity (counts/hour)
Relative Amplitude
Time frame: From enrollment to the end of baseline (2 weeks)
Formula: Relative Amplitude =(M10-L5)/(M10+L5). A value near 1 indicates a strong, well-defined circadian rhythm (high activity during the day and very low activity at night), and a value near 0 indicates a fragmented or "flat" rhythm (little difference between your most active and least active periods).
Interdaily Stability
Time frame: From enrollment to the end of baseline (2 weeks)
The ratio of the variance of the average 24-hour activity profile to the variance of the overall 24-hour data. Actigraphy is collected over 2 weeks and averaged to create a single, representative 24-hour profile. Interdaily Stability values range from 0 to 1, where 0 indicates a total lack of stability and 1 indicates perfect stability. Lower values suggest fragmented, weak, or disrupted circadian rhythms.
Caloric intake timing
Time frame: From enrollment to the end of baseline (2 weeks)
Time of calorie consumption (h:m)
MEQ Score
Time frame: Baseline measure in week 2
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report assessment used to determine an individual's circadian preference (chronotype), ranging from morning-type to evening-type. Scores range from 16 to 86, with higher scores indicating morningness and lower scores indicating eveningness.
PHQ9 Score
Time frame: Baseline measure in week 2
The PHQ-9 is a 9-item, self-report questionnaire used to screen for and measure the severity of depression in clinical trials. It covers the 9 diagnostic criteria for major depressive disorder based on the DSM-IV. Total scores range from 0 to 27, with higher scores indicating higher levels of depression.
PDQ-D5 Score
Time frame: Baseline measure in week 2
The PDQ-D5 is a self-report questionnaire assessing subjective cognitive impairment. It includes five items covering four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. The total score is the sum of the five items, ranging from 0 to 20. Higher scores indicate greater perceived cognitive deficits, while lower scores indicate fewer problems.
PSQI Score
Time frame: Baseline measure in week 2
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality and disturbances over a one-month interval. It measures seven components (quality, latency, duration, efficiency, disturbances, medication, dysfunction) to produce a global score from 0 to 21, where higher scores indicate poorer sleep quality.
Recruitment Rate
Time frame: From study initiation to end of recruitment period (approximately 16 months)
Formula: Total participants enrolled / enrollment time window, with higher numbers indicating better recruitment.
Retention Rate
Time frame: From enrollment to study completion (approximately 19 months)
Formula: (number of participants that complete the study / number of participants that enrolled) x 100, reported as percentage with higher numbers indicating higher retention.
Missing Data Rate
Time frame: From baseline to end of study visit (weeks 1-12)
The missing data rate is defined as the percentage of expected data points for primary outcomes (e.g., daily food logs, daily actigraphy wearing, and survey responses) that were not collected or were unusable at the final study visit. Calculation: (Number of missing data points / Total number of expected data points across all enrolled participants) × 100 reported as a percentage with higher values indicating more missing data. Note: This includes data missing due to participant withdrawal or non-response to specific survey items.
Change in Mediterranean Diet Adherence Screener (13-MEDAS) Score
Time frame: Measured at baseline in week 2 and during intervention in week 10
Adherence to the Mediterranean Diet is assessed using the validated 13-item Mediterranean Diet Adherence Screener (13-MEDAS). The questionnaire evaluates the consumption frequency of Mediterranean dietary staples (e.g., olive oil, vegetables, fruits, nuts, fish, legumes) and frequency of unhealthy food choices (e.g., animal fats, sugar-sweetened beverages). Each item is scored 0 or 1. The total score ranges from 0 to 13, with higher scores indicating greater adherence.
Time-restricted eating adherence
Time frame: Measured throughout nutritional intervention (week 3-11)
Using the time of first and last caloric intake of the day, time-restricted eating adherence is calculated as the percentage of days where all food was consumed within the designated 10 h time window.
Mediterranean Diet Intervention Acceptability
Time frame: End of study (week 10-12)
Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The Mediterranean diet changes were manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data for all participants reported. Higher values indicate diet content modifications were more manageable.
Time-Restricted Eating Intervention Acceptability
Time frame: End of study (week 10-12)
Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The time restriction on calorie intake was manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data reported for Group 2 only (Mediterranean Diet + Time-Restricted Eating). Higher values indicate diet timing modifications were more manageable.
Participant-Reported Global Impression of Change in Depression
Time frame: End of study (week 10-12)
A single-item assessment of the overall change in depression since study entry. Scale: 1 = Very Much Worse, 2 = Much Worse, 3 = Minimally Worse, 4 = No Change, 5 = Minimally Improved, 6 = Much Improved, 7 = Very Much Improved. Higher scores indicate greater improvement.
Perceived Impact of Dietary Changes on Sleep
Time frame: End of study (week 10-12)
A single item ("The dietary changes made during the study had a positive impact on my sleep") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Perceived Impact of Dietary Changes on Metabolic Health
Time frame: End of study (week 10-12)
A single item ("The dietary changes made during the study had a positive impact on my metabolic health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Perceived Impact of Dietary Changes on Overall Health
Time frame: End of study (week 10-12)
A single item ("The dietary changes made during the study had a positive impact on my overall health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact.
Participant-Reported Intent for Long-term Dietary Maintenance
Time frame: End of study (week 10-12)
A single-item assessment of the participant's intention to continue the intervention diet after the study concludes ('I plan to maintain dietary changes from the study moving forward') will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a higher intent to maintain the dietary changes.
6 secondary outcomes
Change in Sleep Duration
Time frame: Baseline (week 1-2) and intervention (week 9-11)
Change in Relative Amplitude
Time frame: Baseline (week 1-2) and intervention (week 9-11)
Change in Interdaily Stability
Time frame: Baseline (weeks 1-2) and intervention (weeks 9-11)
Change in PHQ9
Time frame: Baseline (week 2) and intervention (week 10)
Change in PDQ-D5 Score
Time frame: Baseline (week 2) and intervention (week 10)
Change in PSQI Score
Time frame: Baseline (week 2) and intervention (week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet and Time-Restricted Eating in people with Depression - Major Depressive Disorder, run by University of California, San Diego 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 5 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J McCarthy (858-534-8070, mmccarthy@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset (time frame: From enrollment to the end of baseline (2 weeks)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.