Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

NCT04772651 | Not Yet Recruiting

• 1 other identifier: EK 1087 ex 2021
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

nutrition; mediterranean diet; vagal function; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Change in Vagal function

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

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

Secondary Outcomes (12)

• Change of C-reactive protein (CRP)

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

• Change in Interleukine-6

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

• Change in Oxytocin

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

• Change of Gut microbiome

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

• Change of Body mass Index

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

Study Arms (2)

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)

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)

Other: Normal hospital diet; Other: Psychoeducation on depression

Interventions

Mediterranean Diet OTHER

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

Mediterranean Diet and dietary coaching

Normal hospital diet OTHER

Normal hospital diet

Diet as usual and psychoeducation for depression

dietary coaching OTHER

dietary coaching

Mediterranean Diet and dietary coaching

Psychoeducation on depression OTHER

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

Diet as usual and psychoeducation for depression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Depression

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Sabrina Mörkl, DDr.

CONTACT

004331638581743; sabrina.moerkl@medunigraz.at

Eva Reininghaus, Prof.

CONTACT

eva.reininghaus@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share