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NCT Number: NCT04772651

Mediterranean Diet and the Microbiota Gut Brain Axis 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Other

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

Normal hospital diet

Other

Normal hospital diet

dietary coaching

Other

dietary coaching

Psychoeducation on depression

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change of C-reactive protein (CRP)

    Time frame: 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)

  2. Change in Interleukine-6

    Time frame: 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

  3. Change in Oxytocin

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    measured from serum samples with ELISA

  4. Change of Gut microbiome

    Time frame: 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.

  5. Change of Body mass Index

    Time frame: 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].

  6. Change in Hamilton Scale for Depression (HAMD)

    Time frame: 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

  7. Change in Beck Depression Inventory (BDI)

    Time frame: 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.

  8. Change in Pittsburgh Sleep Quality Inventory (PSQI)

    Time frame: 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.

  9. Change in Adult Attachment Scale

    Time frame: 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

  10. Change in Wiener Ernährungsprotokoll

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    24-hr food recall

  11. Change in Mediterranean Diet Score

    Time frame: 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)

  12. Change in International Physical Acitivity Questionnaire

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Reininghaus, Prof.

CONTACT

[email protected]

Sabrina Mörkl, DDr.

CONTACT

[email protected]

004331638581743

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: MeDiVa

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 26, 2021
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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