Status:

NOT_YET_RECRUITING

Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

Lead Sponsor:

Medical University of Graz

Conditions:

Depression

Eligibility:

All Genders

18-80 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • legally competent persons aged 18-80 years
  • diagnosis of depression according to ICD-10 or DSM.

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2029

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT04772651

Start Date

November 1 2025

End Date

September 30 2029

Last Update

March 14 2023

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