Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression (MeDiVa)

Medical University of Graz

Status: Not yet enrolling

Conditions: Depression

Treatments: Other: Psychoeducation on depression; Other: Mediterranean Diet; Other: dietary coaching; Other: Normal hospital diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04772651

EK 1087 ex 2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups, including a placebo group

Mediterranean Diet and dietary coaching

Experimental group

Description:

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

Treatment:

Other: dietary coaching

Other: Mediterranean Diet

Diet as usual and psychoeducation for depression

Placebo Comparator group

Description:

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)

Treatment:

Other: Normal hospital diet

Other: Psychoeducation on depression