Nutrition's role in treating depression

Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder: A Randomized Open Controlled Trial Study

This study is testing if following the Mediterranean Diet along with regular treatment can help people with depression and high inflammation feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA (Academic / other)
• Locations: 2 sites (Loures, Lisbon District and 1 other locations)
• Trial ID: NCT05745194 on ClinicalTrials.gov

What this trial studies

This study investigates whether promoting adherence to the Mediterranean Diet can reduce symptoms of Major Depressive Disorder (MDD) in patients with elevated inflammation biomarkers. It involves a 12-week multicenter randomized controlled trial with two groups: one receiving dietary counseling alongside standard MDD treatment and the other receiving standard treatment only. The study aims to assess the effectiveness of this dietary intervention and its impact on inflammatory biomarkers, depressive symptoms, and overall quality of life. Follow-up assessments will occur at 6 and 12 months post-intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 diagnosed with MDD, experiencing elevated inflammation biomarkers, and currently undergoing pharmacological treatment.

Not a fit: Patients with autoimmune diseases, thyroid dysfunction, cancer, or those with certain psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel dietary strategy to enhance the treatment of depression, particularly for patients with inflammation-related symptoms.

How similar studies have performed: Other studies have shown promising results with dietary interventions in mental health, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18-70 years old
2. Able to understand and provide informed consent
3. Able to read and write
4. Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria)
5. Score on the Beck Depression Inventory-II scale (BDI-II) \> 13;
6. Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml )
7. Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances
8. Being under pharmacological treatment for depressive disorder

Exclusion Criteria:

1. Diagnosis of autoimmune diseases, thyroid dysfunction or cancer
2. Diagnosis of bipolar disorder, psychotic disorders, eating disorders
3. Self-reported acute infection 2 weeks prior to the blood sample collection
4. Pregnancy or lactation
5. Glucocorticoid medication
6. Prescribed with NMDA Receptor Antagonists
7. Under treatment with brain stimulation techniques for the depressive episode
8. Currently participating in another intervention targeting diet, physical exercise, or MDD treatment

Where this trial is running

Loures, Lisbon District and 1 other locations

• Hospital de Beatriz Ângelo - Hospital de Loures, EPE — Loures, Lisbon District, Portugal (Recruiting)
• Centro Hospitalar de Leiria - Hospital Santo André — Leiria, Portugal (Recruiting)

Study contacts

• Principal investigator: Maria João Heitor, PhD — Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa, Portugal
• Study coordinator: Nuno Sousa-Santos, BSc

Conditions Major Depressive Disorder - MDD; Depression; Major Depressive Disorder; Nutritional Intervention; Randomized Controlled Trial; Mediterranean Diet