MeDiVa: Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

Sponsor

Medical University of Graz (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04772651

Collaborator

(none)

108

Enrollment

Arms

10.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Mediterranean Diet Other: Normal hospital diet Other: dietary coaching Other: Psychoeducation on depression	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mediterranean Diet and dietary coaching 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 Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015) Other: dietary coaching dietary coaching
Placebo Comparator: Diet as usual and psychoeducation for depression 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 Normal hospital diet Other: Psychoeducation on depression Psychoeducation on depression (50minutes once a week for 4 weeks)

Arm

Intervention/Treatment

Experimental: Mediterranean Diet and dietary coaching

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

Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)

Other: dietary coaching

dietary coaching

Placebo Comparator: Diet as usual and psychoeducation for depression

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

Normal hospital diet

Other: Psychoeducation on depression

Psychoeducation on depression (50minutes once a week for 4 weeks)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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