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Not yet recruiting NCT04772651

Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean Diet, Normal hospital diet, dietary coaching, Psychoeducation on depression.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Other Mediterranean Diet
    Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
  • Other Normal hospital diet
    Normal hospital diet
  • Other dietary coaching
    dietary coaching
  • Other Psychoeducation on depression
    Psychoeducation on depression (50minutes once a week for 4 weeks)

Primary outcome measures

  • Change in Vagal function [Time frame: at study entry, after 7 days, after 4 weeks and after 3 months]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04772651 · EK 1087 ex 2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗