Depression
Conditions
Keywords
nutrition, mediterranean diet, vagal function, heart rate variability
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).
Interventions
OTHERMediterranean Diet
Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
OTHERNormal hospital diet
Normal hospital diet
OTHERdietary coaching
dietary coaching
OTHERPsychoeducation on depression
Psychoeducation on depression (50minutes once a week for 4 weeks)
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vagal function | at study entry, after 7 days, after 4 weeks and after 3 months | Vagal function measured by 24-hr ECG (logRSA, SDNN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukine-6 | at study entry, after 7 days, after 4 weeks and after 3 months | Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics |
| Change in Oxytocin | at study entry, after 7 days, after 4 weeks and after 3 months | measured from serum samples with ELISA |
| Change of Gut microbiome | at study entry, after 7 days, after 4 weeks and after 3 months | 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. |
| Change of Body mass Index | at study entry, after 7 days, after 4 weeks and after 3 months | 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 \[kg/m2\]. |
| Change in Hamilton Scale for Depression (HAMD) | at study entry, after 7 days, after 4 weeks and after 3 months | 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 |
| Change of C-reactive protein (CRP) | at study entry, after 7 days, after 4 weeks and after 3 months | CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer) |
| Change in Pittsburgh Sleep Quality Inventory (PSQI) | at study entry, after 7 days, after 4 weeks and after 3 months | 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. |
| Change in Adult Attachment Scale | at study entry, after 7 days, after 4 weeks and after 3 months | 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 |
| Change in Wiener Ernährungsprotokoll | at study entry, after 7 days, after 4 weeks and after 3 months | 24-hr food recall |
| Change in Mediterranean Diet Score | at study entry, after 7 days, after 4 weeks and after 3 months | 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) |
| Change in International Physical Acitivity Questionnaire | at study entry, after 7 days, after 4 weeks and after 3 months | Questionnaire to rate physical activity; Physical activity is given in MET-minutes (METs are multiples of the resting metabolic rate) |
| Change in Beck Depression Inventory (BDI) | at study entry, after 7 days, after 4 weeks and after 3 months | 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. |
Contacts
Primary ContactSabrina Mörkl, DDr.
Backup ContactEva Reininghaus, Prof.
Outcome results
None listed