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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Mediterranean Diet; Other: dietary coaching; Other: Normal hospital diet; Other: Psychoeducation on 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).

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrina Mörkl, DDr.; Phone Number: 004331638581743; Email: sabrina.moerkl@medunigraz.at
• Study Contact Backup: Name: Eva Reininghaus, Prof.; Email: eva.reininghaus@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in Oxytocin	measured from serum samples with ELISA	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.	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].	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	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.	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.	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	at study entry, after 7 days, after 4 weeks and after 3 months
Change in Wiener Ernährungsprotokoll	24-hr food recall	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)	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)	at study entry, after 7 days, after 4 weeks and after 3 months

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2025
• Primary Completion (Anticipated): September 1, 2028
• Study Completion (Anticipated): September 30, 2029

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: nutrition; heart rate variability; mediterranean diet; vagal function
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: EK 1087 ex 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No