Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT06621394
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06621394
Study Brief:
Protocol Section:
NCT06621394