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Recruiting NCT07490782

Nutritional Intervention for College Students With Depression

No phase Interventional Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean Diet, Time-Restricted Eating.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California San Diego — La Jolla

Identifiers

NCT: NCT07490782 · 813542

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗