Mediterranean Diet and Intermittent Fasting for Depression

Overseen By Michael J McCarthy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Investigational drugs

Disqualifiers: Bipolar, Schizophrenia, PTSD, Eating disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I have mild to moderate depression symptoms.

I have been taking the same dose of my weight, metabolism, or mental health medication.

Generally in good physical health

Exclusion Criteria

Elevated risk for suicide

Current alcohol or substance use disorder

My doctor has confirmed I can safely take part in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Participants complete a 2-week baseline logging diet, sleep, activity, and mood

2 weeks

1 visit (in-person)

Treatment

Participants are randomized to Mediterranean Diet or Time-Restricted Eating + Mediterranean Diet and participate in dietary counseling during the 8-week intervention

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for adherence and effectiveness of dietary interventions

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet
• Time-Restricted Eating

How Is the Trial Designed?

Group I: Time-Restricted Eating + Mediterranean Diet Experimental Treatment 2 Interventions

Group II: Mediterranean Diet Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+