Mediterranean Diet and Recurrence of Depression

NCT03081065 | Unknown

• 1 other identifier: ULPGC
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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

Clinical Trial; Depression; Mediterranean, Diet

Outcome Measures

Primary Outcomes (1)

• Time until recurrence of depression (defined as a clinical diagnosis of unipolar depressive disorder made by a Psychiatrist from the research team)

  New diagnoses of episodes of depression (recurrent depression as participants have a history of unipolar depressive disorder).

  From date of randomization until the date of first documented depressive episode diagnosis assessed up to 32 months

Secondary Outcomes (6)

• Change in depressive symptoms using the Montgomery Asberg Depression Rating Scale

  Yearly (baseline, 1-year, 2-year of follow-up)

• Change in quality of life using the SF-36 quality of life questionnaire

  Yearly (baseline, 1-year, 2-year of follow-up)

• Change in biochemical parameters (plasma levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, glucose, protein C Reactive)

  Yearly (baseline, 1-year, 2-year of follow-up)

• Change in microbiota in stool samples

  Change from baseline to the second year of follow-up

• Incidence of physical diseases (Clinically confirmed after an exhaustive review of clinical records of the participants)

  From date of randomization until the date of first documented physical disease diagnosis assessed up to 32 months

Study Arms (3)

Mediterranean Diet+ extra virgin olive oil

EXPERIMENTAL

Free supply with extra virgin olive oil and nuts plus educational advice

Dietary Supplement: Mediterranean Diet

Mediterranean Diet+ tree nuts

EXPERIMENTAL

Free supply with tree nuts plus educational advice

Dietary Supplement: Mediterranean Diet

Control

NO INTERVENTION

Usual care

Interventions

Mediterranean Diet DIETARY_SUPPLEMENT

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

Mediterranean Diet+ extra virgin olive oil; Mediterranean Diet+ tree nuts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults
• with a previous diagnosis of depression in the last 5 years and in a stage of total or partial remission

You may not qualify if:

• presence of comorbid psychiatric disorders (anxiety, bipolar disorder, personality disorders, alcohol and drug abuse, mania, psychosis)
• presence of severe medical condition with survival lower than one year)
• history of food allergy with hypersensitivity to any of the components of olive oil or nuts
• presence of disorders of chewing or swallowing
• difficulties to change dietary habits
• institutionalized patients and those participants who lack autonomy

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead
• Instituto de Salud Carlos III: collaborator

Related Publications (3)

• Cabrera-Suarez BM, Lahortiga-Ramos F, Sayon-Orea C, Hernandez-Fleta JL, Gonzalez-Pinto A, Molero P, Vega-Perez R, Sanchez-Villegas A; PREDI-DEP investigators. Effect of a dietary intervention based on the Mediterranean diet on the quality of life of patients recovered from depression: Analysis of the PREDIDEP randomized trial. Exp Gerontol. 2023 May;175:112149. doi: 10.1016/j.exger.2023.112149. Epub 2023 Mar 20.

  PMID: 36933773 DERIVED

• Cabrera-Suarez B, Pla J, Gonzalez-Pinto A, Hernandez J, Chiclana-Actis C, Ortuno F, Florido-Rodriguez M, Sanchez-Villegas A, Investigators PD. 'Effectiveness of a remote nutritional intervention to increase the adherence to the Mediterranean diet among recovered depression patients'. Nutr Neurosci. 2023 Aug;26(8):696-705. doi: 10.1080/1028415X.2022.2081448. Epub 2022 Jul 11.

  PMID: 35816397 DERIVED

• Sanchez-Villegas A, Cabrera-Suarez B, Molero P, Gonzalez-Pinto A, Chiclana-Actis C, Cabrera C, Lahortiga-Ramos F, Florido-Rodriguez M, Vega-Perez P, Vega-Perez R, Pla J, Calvino-Cabada MJ, Ortuno F, Navarro S, Almeida Y, Hernandez-Fleta JL. Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol. BMC Psychiatry. 2019 Feb 11;19(1):63. doi: 10.1186/s12888-019-2036-4.

  PMID: 30744589 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Almudena Sanchez-Villegas, PhD

CONTACT

+34 928452794; almudena.sanchez@ulpgc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 15, 2017
• Study Start: March 20, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share