Recruiting

Med-Diet & TRE

Sponsor:

UCLA

Code:

NCT07490782

Conditions

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mediterranean Diet

Time-Restricted Eating

Study Details

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

Study ID

NCT07490782

Start date

Mar, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mediterranean Diet

experimental: Time-Restricted Eating + Mediterranean Diet

Interventions

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.

Time-Restricted Eating

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

Primary outcome measure

  • Sleep onset [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • Sleep offset [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • Sleep Duration [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • M10 [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • L5 [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • Relative Amplitude [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • Interdaily Stability [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • Caloric intake timing [ Time Frame: From enrollment to the end of baseline (2 weeks) ]
  • MEQ Score [ Time Frame: Baseline measure in week 2 ]
  • PHQ9 Score [ Time Frame: Baseline measure in week 2 ]
  • PDQ-D5 Score [ Time Frame: Baseline measure in week 2 ]
  • PSQI Score [ Time Frame: Baseline measure in week 2 ]
  • Recruitment Rate [ Time Frame: From study initiation to end of recruitment period (approximately 16 months) ]
  • Retention Rate [ Time Frame: From enrollment to study completion (approximately 19 months) ]
  • Missing Data Rate [ Time Frame: From baseline to end of study visit (weeks 1-12) ]
  • Change in Mediterranean Diet Adherence Screener (13-MEDAS) Score [ Time Frame: Measured at baseline in week 2 and during intervention in week 10 ]
  • Time-restricted eating adherence [ Time Frame: Measured throughout nutritional intervention (week 3-11) ]
  • Mediterranean Diet Intervention Acceptability [ Time Frame: End of study (week 10-12) ]
  • Time-Restricted Eating Intervention Acceptability [ Time Frame: End of study (week 10-12) ]
  • Participant-Reported Global Impression of Change in Depression [ Time Frame: End of study (week 10-12) ]
  • Perceived Impact of Dietary Changes on Sleep [ Time Frame: End of study (week 10-12) ]
  • Perceived Impact of Dietary Changes on Metabolic Health [ Time Frame: End of study (week 10-12) ]
  • Perceived Impact of Dietary Changes on Overall Health [ Time Frame: End of study (week 10-12) ]
  • Participant-Reported Intent for Long-term Dietary Maintenance [ Time Frame: End of study (week 10-12) ]

Central Contacts and Locations

Central contacts

Michael J McCarthy

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

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Michael J McCarthy

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

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-03-24.