An interventional study of Mediterranean Diet and Time-Restricted Eating in Depression - Major Depressive Disorder, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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:
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:
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Mediterranean Diet
Behavioral: Mediterranean Diet · Behavioral: Time-Restricted Eating
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.
Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.
Sleep onset
Actigraphy determined sleep onset time (h:m)
Time frame: From enrollment to the end of baseline (2 weeks)
Sleep offset
Actigraphy determined sleep offset time (h:m)
Time frame: 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.
Time frame: From enrollment to the end of baseline (2 weeks)
M10
Average activity level from 10 hours of highest activity (counts/hour)
Time frame: From enrollment to the end of baseline (2 weeks)
L5
Average activity level from 5 hours of lowest activity (counts/hour)
Time frame: 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).
Time frame: 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.
Time frame: From enrollment to the end of baseline (2 weeks)
Caloric intake timing
Time of calorie consumption (h:m)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline measure in week 2
Recruitment Rate
Formula: Total participants enrolled / enrollment time window, with higher numbers indicating better recruitment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of study (week 10-12)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (week 2) and intervention (week 10)
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