Impact of Mediterranean Diet and Mindful Eating on Depression in Obese Individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how a Mediterranean Diet and Mindful Eating can affect depression severity in individuals with obesity and major depressive disorder. Participants will be randomly assigned to one of four groups: Mediterranean Diet, Mindful Eating, a combination of both, or a befriending control group. The intervention lasts for 12 weeks and includes five individual nutrition counseling sessions, followed by a 12-week follow-up period. The primary focus is on measuring changes in depression severity, along with secondary outcomes related to quality of life and dietary adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Presence of clinically diagnosed major depression
* At least moderate depression severity: BDI-II ≥ 20
* obesity: BMI ≥ 30 kg/m2
* Stable co-intervention: no change in the type, dosage or frequency of antidepressant medication and/or psychotherapy four weeks before and during the study
* Low adherence to the mediterranean diet: MEDAS \< 10
* Low adherence to mindful eating: MEI \< 5.13

Exclusion Criteria:

* Diseases of the gastrointestinal tract that do not allow adequate implementation of the intervention (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma)
* Metabolic diseases with strong impact on intervention (e.g. type 1 diabetes mellitus, chronic kidney disease)
* Severe food allergies and intolerances, that do not allow adequate implementation of the intervention
* Diagnosed, current psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
* intake of antibiotics in the last three months current substance abuse
* Pregnancy and breatfeeding
* Suicidal ideation
* unable to participate or complete questionnaires

Healthy Volunteers:

samples of 32 healthy volunteers are included for microbiome analysis only (

inclusion criteria:

* age ≥ 18 years
* BMI 20 - 30 kg/m\^2

exclusion criteria:

* depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
* high adhernece to mediterranean diet: MEDAS ≥ 10
* high adherence to mindful eating: MEI ≥ 5.13
* Diseases of the gastrointestinal tract or metabilic diseases (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma, type 1 diabetes mellitus)

  \-- intake of antibiotics in the last three months current substance abuse
* pregnancy or breastfeeding

Where it's running

• Robert Bosch Center for Integrative Medicine and Health
  Stuttgart, Germany Recruiting

Study contacts

• Study coordinator: Alina Moosburner, MSc
• Email: alina.moosburner@med.uni-tuebingen.de
• Phone: +4971181013764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.