Impact of Mediterranean Diet and Mindful Eating on Depression in Obese Individuals
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
This study is testing if following a Mediterranean Diet and practicing Mindful Eating can help reduce depression in people who are obese and struggling with major depressive disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Stuttgart) |
| Trial ID | NCT06621394 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically diagnosed major depression and obesity (BMI ≥ 30 kg/m2).
Not a fit: Patients with gastrointestinal diseases, severe food allergies, or other significant psychological comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a holistic treatment option for patients suffering from both obesity and major depressive disorder.
How similar studies have performed: Previous studies have shown positive effects of the Mediterranean Diet on mental health, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stuttgart
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.