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Official title The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
ClinicalTrials.gov ID: NCT06621394
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Diseases of the gastrointestinal tract that do not allow adequate implementation of the intervention (e.g. irritable bowel syndrome, post-bariatric...
- 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
See the full eligibility 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
- 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...
- pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Stuttgart, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stuttgart, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.