Nutritional Intervention for College Students With Depression

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 Overview

• Status: Recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Mediterranean Diet; Behavioral: Time-Restricted Eating

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J McCarthy; Phone Number: 858-534-8070; Email: mmccarthy@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Contact: Michael J McCarthy; Phone Number: 858-534-8070; Email: mmccarthy@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet	Behavioral: Mediterranean Diet; 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.
Experimental: Time-Restricted Eating + Mediterranean Diet	Behavioral: Mediterranean Diet; 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.; Behavioral: Time-Restricted Eating; Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep onset	Actigraphy determined sleep onset time (h:m)	From enrollment to the end of baseline (2 weeks)
Sleep offset	Actigraphy determined sleep offset time (h:m)	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.	From enrollment to the end of baseline (2 weeks)
M10	Average activity level from 10 hours of highest activity (counts/hour)	From enrollment to the end of baseline (2 weeks)
L5	Average activity level from 5 hours of lowest activity (counts/hour)	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).	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.	From enrollment to the end of baseline (2 weeks)
Caloric intake timing	Time of calorie consumption (h:m)	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.	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.	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.	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.	Baseline measure in week 2
Recruitment Rate	Formula: Total participants enrolled / enrollment time window, with higher numbers indicating better recruitment.	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.	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.	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 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 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.	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.	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.	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.	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.	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.	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.	End of study (week 10-12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	Baseline (week 2) and intervention (week 10)

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; nutritional intervention; Mediterranean diet; time-restricted eating
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Fasting; Intermittent Fasting; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: 813542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No