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The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
The present study investigates the effect of Mediterranean Diet and Mindful Eating on depression severity in people with obesity and major depressive disorder. The factorial design allows to investigate potential synergistic effects of the interventions. Participants will be randomized to one of the four intervention groups (mediterranean diet, mindful eating, their combination and a befriending control group). The intervention consists of a 12-week period, followed by a 12-week follow up. The primary outcome is…
ClinicalTrials.gov IDNCT06621394
PhaseNA
Enrollment64
SponsorUniversity Hospital Tuebingen
Age18 Years and older
SexALL
Conditions studied
Depressive Disorder, Major
About this study
The present study investigates the effect of Mediterranean Diet and Mindful Eating on depression severity in people with obesity and major depressive disorder. The factorial design allows to investigate potential synergistic effects of the interventions. Participants will be randomized to one of the four intervention groups (mediterranean diet, mindful eating, their combination and a befriending control group). The intervention consists of a 12-week period, followed by a 12-week follow up. The primary outcome is depression severity.
Interventions
- Other: nutritional intervention — nutritional intervention to mediterranean diet
- Behavioral: Mindful Eating — intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
- Other: Attention Control — Befreinding Control Group: Provision of same amout of time and attention, without having an intervention, e.g. talking about hobbies and interests, playing card games
Primary outcomes
- Depression severity (12 weeks)
Eligibility information
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
Study locations
- Robert Bosch Center for Integrative Medicine and Health, Stuttgart, 70376 Germany
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.