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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
108
Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
Normal hospital diet
dietary coaching
Change in Vagal function
Vagal function measured by 24-hr ECG (logRSA, SDNN)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change of C-reactive protein (CRP)
CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Interleukine-6
Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Oxytocin
measured from serum samples with ELISA
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change of Gut microbiome
16S sequencing of a stool sample, gut microbiome data will be analyzed with QIIME2 with regard to diversity metrices (alpha-diversity, beta-diversity) and differential bacterial abundance.
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change of Body mass Index
Weight will be measured with a calibrated scale, height will be measured with a non-expandable measuring tape. BMI will be calculated according to the formula \[kg/m2\].
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Hamilton Scale for Depression (HAMD)
Scale to rate severity of depressive symptoms; Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression
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Psychoeducation on depression (50minutes once a week for 4 weeks)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Beck Depression Inventory (BDI)
Self-rated scale to rate severity of depressive symptoms; Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Pittsburgh Sleep Quality Inventory (PSQI)
Questionnaire to assess sleep quality; global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Adult Attachment Scale
Questionnaire to assess attachment style in adults; The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant", defined as: * Secure = high scores on Close and Depend subscales, low score on Anxiety subscale * Anxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales * Avoidant = low scores on Close, Depend, and Anxiety subscales
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Wiener Ernährungsprotokoll
24-hr food recall
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Mediterranean Diet Score
Questionnaire rating the diet according to Mediterranean dietary style; three categories of adherence to the Mediterranean diet can be calculated (≤5, 6-9 and ≥10 points of the 14-item questionnaire)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in International Physical Acitivity Questionnaire
Questionnaire to rate physical activity; Physical activity is given in MET-minutes (METs are multiples of the resting metabolic rate)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months