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Clinical Trials in Germany / NCT06621394
Recruiting Not applicable

The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder

NCT06621394 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-11-05
Last updated
2025-04-08

Condition(s) studied

Depressive Disorder, Major

Investigational drug(s) / intervention(s)

nutritional interventionMindful EatingAttention Control

nutritional intervention: nutritional intervention to mediterranean diet

Mindful Eating: intervention regarding mindful eating, e.g. attention while eating, apprechiation of food

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Robert Bosch Center for Integrative Medicine and Health Stuttgart Germany Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06621394 on ClinicalTrials.gov ↗ ← All trials in Germany