An interventional study of Mediterranean Diet and Normal hospital diet in Depression, sponsored by Medical University of Graz. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science
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).
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 108 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks)
Other: Mediterranean Diet · Other: dietary coaching
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)
Other: Normal hospital diet · Other: Psychoeducation on depression
Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
Normal hospital diet
dietary coaching
Psychoeducation on depression (50minutes once a week for 4 weeks)
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2025; primary completion for Sep 2028, 34 months later.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 34 months is above that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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