Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

NCT ID: NCT04772651

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2029-09-30

Brief Summary

The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Subjects meeting the inclusion criteria will be randomized in a group recieiving a Mediterranean diet (3 mediterranean meals a day) and dietary coaching (1 session per week for 4 weeks) or a group with conventional hospital food and psychoeducation on depression (1 session per week for 4 weeks).

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet and dietary coaching

Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks)

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: OTHER

Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)

dietary coaching

Intervention Type: OTHER

dietary coaching

Diet as usual and psychoeducation for depression

Patients receive normal hospital diet with 3 meals a day for 4 weeks and psychoeducation sessions (á 50 minutes once a week for 4 weeks)

Group Type: PLACEBO_COMPARATOR

Normal hospital diet

Intervention Type: OTHER

Normal hospital diet

Psychoeducation on depression

Intervention Type: OTHER

Psychoeducation on depression (50minutes once a week for 4 weeks)

Interventions

Mediterranean Diet

Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)

Intervention Type: OTHER

Normal hospital diet

Normal hospital diet

Intervention Type: OTHER

dietary coaching

dietary coaching

Intervention Type: OTHER

Psychoeducation on depression

Psychoeducation on depression (50minutes once a week for 4 weeks)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• legally competent persons aged 18-80 years
• diagnosis of depression according to ICD-10 or DSM.

Exclusion Criteria

• other neurologic or psychiatric disorders (epilepsy, brain tumor, head injury, head surgery, trauma)
• drug or alcohol dependency
• acute suicidality
• heart disorders, disorders of the circulatory system
• pregnancy and period of breastfeeding
• severe mental disability, dementia (MMST<20)
• autoimmune disorder, severe immunosuppression (Lupus, HIV, multiple sclerosis)
• therapy with antibiotics in the last month
• chronic laxative abuse
• acute infectious diarrhea
• GI surgeries (except appendectomy)
• regular intake of probiotics, antibiotics and food supplements (1 month before and during the study)
• food allergies or other food intolerances which are incompatible with a mediterranean diet
• vegetarians, vegans

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sabrina Mörkl, DDr.

Role: CONTACT

sabrina.moerkl@medunigraz.at

004331638581743

Eva Reininghaus, Prof.

Role: CONTACT

eva.reininghaus@medunigraz.at

Other Identifiers

EK 1087 ex 2021

Identifier Type: -

Identifier Source: org_study_id