NCT06621394Recruiting
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 5 Nov 2024
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Obesity, Depression
- NCT number
- NCT06621394
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 5 Nov 2024 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
- 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
Other
- 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 (
- high adhernece to mediterranean diet: MEDAS ≥ 10
- high adherence to mindful eating: MEI ≥ 5.13
- pregnancy or breastfeeding
Who the study is looking for
- 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
- age ≥ 18 years
- BMI 20 - 30 kg/m\^2
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert Bosch Center for Integrative Medicine and Health Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.