Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

Depression Clinical Trial

— MeDiVa  

Official title:

Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04772651
• Other study ID #: EK 1087 ex 2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2025
• Est. completion date: September 30, 2029

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: Sabrina Mörkl, DDr.
• Phone: 004331638581743
• Email: sabrina.moerkl[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: September 30, 2029
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Mediterranean Diet
Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
• Normal hospital diet
Normal hospital diet
• dietary coaching
dietary coaching
• Psychoeducation on depression
Psychoeducation on depression (50minutes once a week for 4 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vagal function	Vagal function measured by 24-hr ECG (logRSA, SDNN)	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	Change of C-reactive protein (CRP)	CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	Change in Interleukine-6	Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	Change in Oxytocin	measured from serum samples with ELISA	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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.	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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].	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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.	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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.	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	Change in Wiener Ernährungsprotokoll	24-hr food recall	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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)	at study entry, after 7 days, after 4 weeks and after 3 months
Secondary	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)	at study entry, after 7 days, after 4 weeks and after 3 months