Clinical trial NCT06621394: The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Official title: The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder - a Randomized Controlled Study With Mulitfactorial Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: depression
mediterranean diet
mindfulnes eating
nutrition
obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Center for Integrative Medicine and Health
name: Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart
name: Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen
First posted: 2024-10-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: TREATMENT

Brief 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.

Detailed description: Depression and obesity are highly prevalent diseases that are strongly correlated. There is a growing gap in care and treatment options for those affected. The effectiveness of a Mediterranean Diet on mental health has already been shown in various studies. Additionally to physiological effects of nutrient intake, also the psychological factor of changing the way of eating seem to play a role. The present study investigates the effect of a Mediterranean Diet and Mindful Eating on depression severity in people with obesity and clinically diagnosed 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, where five individual nutrition consueling meetings will take place, followed by a 12-week follow up. The primary outcome is depression severity. Secondary outcomes and analyzes include quality of life, self-efficacy, mediterranean diet and mindfulness eating scores, anthropometric measurements, as well as mediator and moderator analysis, a microbiome analysis, a qualitative evaluation and an economic analysis.

Eligibility criteria: 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 outcomes:
measure: Depression severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Depression severity, self assessment
timeFrame: 24 weeks
measure: Depression Remission Rates
timeFrame: 12 weeks, 24 weeks
measure: Quality of Life
timeFrame: 12 weeks, 24 weeks
measure: Self-efficacy
timeFrame: 12 weeks, 24 weeks
measure: Health status
timeFrame: 12 weeks,
measure: Adhernece to Mediterranean Diet
timeFrame: 12 weeks, 24 weeks
measure: Adherence to Mindfulnes Eating
timeFrame: 12 weeks, 24 weeks
measure: Depression severity, rater assesment
timeFrame: 12 weeks
measure: BMI
timeFrame: 12 weeks, 24 weeks
measure: Waist to Hip ratio
timeFrame: 12 weeks, 24 weeks
measure: Body composition: muscle mass
timeFrame: 12 weeks, 24 weeks
measure: Body composition: fat mass
timeFrame: 12 weeks, 24 weeks
measure: adverse events
timeFrame: 12 weeks, 24 weeks
measure: Microbiome Analysis
timeFrame: 12 weeks
measure: cost-utility analysis
timeFrame: 12 weeks
measure: Qualitative evaluation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Center for Integrative Medicine and Health
Study officials:
References: