Clinical trial NCT04772651: Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression
Official title: Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: nutrition
mediterranean diet
vagal function
heart rate variability
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Change in Vagal function
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
Secondary outcomes:
measure: Change of C-reactive protein (CRP)
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Interleukine-6
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Oxytocin
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change of Gut microbiome
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change of Body mass Index
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Hamilton Scale for Depression (HAMD)
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Beck Depression Inventory (BDI)
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Adult Attachment Scale
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Wiener Ernährungsprotokoll
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Mediterranean Diet Score
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in International Physical Acitivity Questionnaire
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
Other outcomes:
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