The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Recruiting · NCT06621394 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Tuebingen
View the official record on ClinicalTrials.gov →Interventions studied
Attention ControlMindful Eatingnutritional intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Robert Bosch Center for Integrative Medicine and Health - Stuttgart, Germany