Nutritional Intervention for College Students With Depression

NCT07490782 | Recruiting

• 1 other identifier: 813542
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Depression - Major Depressive Disorder

Keywords

time-restricted eating; Mediterranean diet; nutritional intervention; feasibility

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (6)

• Change in Sleep Duration

  Baseline (week 1-2) and intervention (week 9-11)

• Change in Relative Amplitude

  Baseline (week 1-2) and intervention (week 9-11)

• Change in Interdaily Stability

  Baseline (weeks 1-2) and intervention (weeks 9-11)

• Change in PHQ9

  Baseline (week 2) and intervention (week 10)

• Change in PDQ-D5 Score

  Baseline (week 2) and intervention (week 10)

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

Behavioral: Mediterranean Diet

Time-Restricted Eating + Mediterranean Diet

EXPERIMENTAL

Behavioral: Mediterranean Diet; Behavioral: Time-Restricted Eating

Interventions

Mediterranean Diet BEHAVIORAL

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.

Mediterranean Diet; Time-Restricted Eating + Mediterranean Diet

Time-Restricted Eating BEHAVIORAL

Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.

Time-Restricted Eating + Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Michael J McCarthy

CONTACT

858-534-8070; mmccarthy@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)