DepressionMeDiVaNCT04772651
Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression
A study testing Mediterranean Diet, Normal hospital diet and dietary coaching in people with Depression, run by Medical University of Graz.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Mediterranean Diet, Normal hospital diet and dietary coaching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- legally competent persons aged 18-80 years
- diagnosis of depression according to ICD-10 or DSM.
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Eva Reininghaus, Prof. contact
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression
- Being tested
- Mediterranean Diet, Normal hospital diet, dietary coaching, Psychoeducation on depression
- Keywords
- nutrition, mediterranean diet, vagal function, heart rate variability
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
Normal hospital dietOther
Normal hospital diet
dietary coachingOther
dietary coaching
Psychoeducation on depressionOther
Psychoeducation on depression (50minutes once a week for 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet and dietary coaching | Experimental | Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks) Receives: Other: Mediterranean Diet; Other: dietary coaching |
| Diet as usual and psychoeducation for depression | Placebo comparator | 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) Receives: Other: Normal hospital diet; Other: Psychoeducation on depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vagal function
Vagal function measured by 24-hr ECG (logRSA, SDNN)
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Secondary outcomes (12)
Change of C-reactive protein (CRP)
CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)
Measured: 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
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Oxytocin
measured from serum samples with ELISA
Measured: 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.
Measured: 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].
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Wiener Ernährungsprotokoll
24-hr food recall
Measured: 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)
Measured: 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)
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Nov 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772651
- Sponsor's protocol ID
- EK 1087 ex 2021
- Acronym
- MeDiVa
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?
- ClinicalTrials.gov ID
- NCT04772651
- Acronym / sponsor ID
- MeDiVa / EK 1087 ex 2021
- Conditions
- Depression
- Keywords
- nutrition, mediterranean diet, vagal function, heart rate variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet and dietary coaching | Experimental | Other: Mediterranean Diet, Other: dietary coachingPatients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks) |
| Diet as usual and psychoeducation for depression | Placebo comparator | Other: Normal hospital diet, Other: Psychoeducation on depressionPatients receive normal hospital diet with 3 meals a day for 4 weeks and psychoeducation sessions (á 50 minutes once a week for 4 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- legally competent persons aged 18-80 years
- diagnosis of depression according to ICD-10 or DSM.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietDiet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015) | Other | Mediterranean Diet and dietary coaching |
| Normal hospital dietNormal hospital diet | Other | Diet as usual and psychoeducation for depression |
| dietary coachingdietary coaching | Other | Mediterranean Diet and dietary coaching |
| Psychoeducation on depressionPsychoeducation on depression (50minutes once a week for 4 weeks) | Other | Diet as usual and psychoeducation for depression |
Primary outcome
Change in Vagal function
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Vagal function measured by 24-hr ECG (logRSA, SDNN)
12 secondary outcomes
Change of C-reactive protein (CRP)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Interleukine-6
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Oxytocin
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change of Gut microbiome
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change of Body mass Index
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Hamilton Scale for Depression (HAMD)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Beck Depression Inventory (BDI)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Adult Attachment Scale
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Wiener Ernährungsprotokoll
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Mediterranean Diet Score
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Change in International Physical Acitivity Questionnaire
Time frame: at study entry, after 7 days, after 4 weeks and after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Reininghaus, Prof. contact
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet, Normal hospital diet and dietary coaching in people with Depression, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Mörkl, DDr. (004331638581743, sabrina.moerkl@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vagal function (time frame: at study entry, after 7 days, after 4 weeks and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.