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Mediterranean Diet and Recurrence of Depression

NCT03081065 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2017-03-15

No results posted yet for this study

Summary

OBJECTIVES:To assess the effect of the intervention with Mediterranean Diet (MD) supplemented with extra virgin olive oil (EVOO) or tree nuts (TN) during 2 years (compared to a control group without intervention) on the risk of recurrence of unipolar depressive disorder in patients with partial or total remission for unipolar depressive disorder (1). Differences between groups in changes in residual symptoms (2), quality of life (QL) (3), biochemical parameters (4) and in the risk of medical/psychiatric co-morbidities (5) will be also analyzed. Finally, gut microbiota and its changes will be collected and compared between groups (6). METHODS: Multicenter clinical trial with 3 arms of intervention (MD+EVOO; MD+TN;control) during 2 years. Adults with previous episodes of unipolar depressive disorder in partial or total remission stage (determined through Montgomery-Asberg questionnaire and MINI interview) will be included. Participants with current depression, psychiatric co-morbid disorders or with problems to follow dietary recommendations will be excluded. A recurrence ratio of 35% in the MD groups and of 50% in the control group will be considered (Hazard Ratio: 0.7). We estimate a sample size of 720 participants (750 to count for losses) (90% power and 5% alpha error). Intervention will be performed through postal mail (recipes and information), email, phone y new technologies (Web page/mobile app) with periodic contacts with psychiatrics and dieticians and postal mail for free EVOO and nuts supply. Information from participants will be gathered with validated questionnaires of diet, physical activity, QL, or symptoms using postal mail, email, Web page or the phone. The analyses will be performed by intention to treat.

Conditions

Interventions

DIETARY_SUPPLEMENT

Mediterranean Diet

Nutritional advice to follow a Mediterranean diet and supplementation with extra virgin olive oil and nuts

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • University of Las Palmas de Gran Canaria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2019-11-30
Completion
2019-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081065 on ClinicalTrials.gov