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

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediterranean Diet
Normal hospital diet
dietary coaching
Psychoeducation on depression
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring nutrition, mediterranean diet, vagal function, heart rate variability

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mediterranean Diet and dietary coaching

    Diet as usual and psychoeducation for depression

    Arm Description

    Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks)

    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)

    Outcomes

    Primary Outcome Measures

    Change in Vagal function
    Vagal function measured by 24-hr ECG (logRSA, SDNN)

    Secondary Outcome Measures

    Change of C-reactive protein (CRP)
    CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)
    Change in Interleukine-6
    Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics
    Change in Oxytocin
    measured from serum samples with ELISA
    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.
    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].
    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
    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.
    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.
    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
    Change in Wiener Ernährungsprotokoll
    24-hr food recall
    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)
    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)

    Full Information

    First Posted
    February 23, 2021
    Last Updated
    March 13, 2023
    Sponsor
    Medical University of Graz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04772651
    Brief Title
    Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression
    Acronym
    MeDiVa
    Official Title
    Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2025 (Anticipated)
    Primary Completion Date
    September 1, 2028 (Anticipated)
    Study Completion Date
    September 30, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    nutrition, mediterranean diet, vagal function, heart rate variability

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mediterranean Diet and dietary coaching
    Arm Type
    Experimental
    Arm Description
    Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks)
    Arm Title
    Diet as usual and psychoeducation for depression
    Arm Type
    Placebo Comparator
    Arm Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Mediterranean Diet
    Intervention Description
    Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
    Intervention Type
    Other
    Intervention Name(s)
    Normal hospital diet
    Intervention Description
    Normal hospital diet
    Intervention Type
    Other
    Intervention Name(s)
    dietary coaching
    Intervention Description
    dietary coaching
    Intervention Type
    Other
    Intervention Name(s)
    Psychoeducation on depression
    Intervention Description
    Psychoeducation on depression (50minutes once a week for 4 weeks)
    Primary Outcome Measure Information:
    Title
    Change in Vagal function
    Description
    Vagal function measured by 24-hr ECG (logRSA, SDNN)
    Time Frame
    at study entry, after 7 days, after 4 weeks and after 3 months
    Secondary Outcome Measure Information:
    Title
    Change of C-reactive protein (CRP)
    Description
    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
    Title
    Change in Interleukine-6
    Description
    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
    Title
    Change in Oxytocin
    Description
    measured from serum samples with ELISA
    Time Frame
    at study entry, after 7 days, after 4 weeks and after 3 months
    Title
    Change of Gut microbiome
    Description
    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
    Title
    Change of Body mass Index
    Description
    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
    Title
    Change in Hamilton Scale for Depression (HAMD)
    Description
    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
    Title
    Change in Beck Depression Inventory (BDI)
    Description
    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
    Title
    Change in Pittsburgh Sleep Quality Inventory (PSQI)
    Description
    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
    Title
    Change in Adult Attachment Scale
    Description
    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
    Title
    Change in Wiener Ernährungsprotokoll
    Description
    24-hr food recall
    Time Frame
    at study entry, after 7 days, after 4 weeks and after 3 months
    Title
    Change in Mediterranean Diet Score
    Description
    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
    Title
    Change in International Physical Acitivity Questionnaire
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sabrina Mörkl, DDr.
    Phone
    004331638581743
    Email
    sabrina.moerkl@medunigraz.at
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eva Reininghaus, Prof.
    Email
    eva.reininghaus@medunigraz.at

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

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