Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04772651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-14
First Post:
2021-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vagal function', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Vagal function measured by 24-hr ECG (logRSA, SDNN)'}], 'secondaryOutcomes': [{'measure': 'Change of C-reactive protein (CRP)', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)'}, {'measure': 'Change in Interleukine-6', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics'}, {'measure': 'Change in Oxytocin', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'measured from serum samples with ELISA'}, {'measure': 'Change of Gut microbiome', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': '16S sequencing of a stool sample, gut microbiome data will be analyzed with QIIME2 with regard to diversity metrices (alpha-diversity, beta-diversity) and differential bacterial abundance.'}, {'measure': 'Change of Body mass Index', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Weight will be measured with a calibrated scale, height will be measured with a non-expandable measuring tape. BMI will be calculated according to the formula \\[kg/m2\\].'}, {'measure': 'Change in Hamilton Scale for Depression (HAMD)', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Scale to rate severity of depressive symptoms; Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression'}, {'measure': 'Change in Beck Depression Inventory (BDI)', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Self-rated scale to rate severity of depressive symptoms; Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.'}, {'measure': 'Change in Pittsburgh Sleep Quality Inventory (PSQI)', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Questionnaire to assess sleep quality; global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.'}, {'measure': 'Change in Adult Attachment Scale', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Questionnaire to assess attachment style in adults; The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant", defined as:\n\n* Secure = high scores on Close and Depend subscales, low score on Anxiety subscale\n* Anxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales\n* Avoidant = low scores on Close, Depend, and Anxiety subscales'}, {'measure': 'Change in Wiener Ernährungsprotokoll', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': '24-hr food recall'}, {'measure': 'Change in Mediterranean Diet Score', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Questionnaire rating the diet according to Mediterranean dietary style; three categories of adherence to the Mediterranean diet can be calculated (≤5, 6-9 and ≥10 points of the 14-item questionnaire)'}, {'measure': 'Change in International Physical Acitivity Questionnaire', 'timeFrame': 'at study entry, after 7 days, after 4 weeks and after 3 months', 'description': 'Questionnaire to rate physical activity; Physical activity is given in MET-minutes (METs are multiples of the resting metabolic rate)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'mediterranean diet', 'vagal function', 'heart rate variability'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.', 'detailedDescription': 'After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Subjects meeting the inclusion criteria will be randomized in a group recieiving a Mediterranean diet (3 mediterranean meals a day) and dietary coaching (1 session per week for 4 weeks) or a group with conventional hospital food and psychoeducation on depression (1 session per week for 4 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* legally competent persons aged 18-80 years\n* diagnosis of depression according to ICD-10 or DSM.\n\nExclusion Criteria:\n\n* other neurologic or psychiatric disorders (epilepsy, brain tumor, head injury, head surgery, trauma)\n* drug or alcohol dependency\n* acute suicidality\n* heart disorders, disorders of the circulatory system\n* pregnancy and period of breastfeeding\n* severe mental disability, dementia (MMST\\<20)\n* autoimmune disorder, severe immunosuppression (Lupus, HIV, multiple sclerosis)\n* therapy with antibiotics in the last month\n* chronic laxative abuse\n* acute infectious diarrhea\n* GI surgeries (except appendectomy)\n* regular intake of probiotics, antibiotics and food supplements (1 month before and during the study)\n* food allergies or other food intolerances which are incompatible with a mediterranean diet\n* vegetarians, vegans'}, 'identificationModule': {'nctId': 'NCT04772651', 'acronym': 'MeDiVa', 'briefTitle': 'Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?', 'orgStudyIdInfo': {'id': 'EK 1087 ex 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet and dietary coaching', 'description': 'Patients receive 3 Mediterranean meals a day for 4 weeks and dietary coaching sessions (á 50 minutes once a week for 4 weeks)', 'interventionNames': ['Other: Mediterranean Diet', 'Other: dietary coaching']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Diet as usual and psychoeducation for depression', 'description': 'Patients receive normal hospital diet with 3 meals a day for 4 weeks and psychoeducation sessions (á 50 minutes once a week for 4 weeks)', 'interventionNames': ['Other: Normal hospital diet', 'Other: Psychoeducation on depression']}], 'interventions': [{'name': 'Mediterranean Diet', 'type': 'OTHER', 'description': 'Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)', 'armGroupLabels': ['Mediterranean Diet and dietary coaching']}, {'name': 'Normal hospital diet', 'type': 'OTHER', 'description': 'Normal hospital diet', 'armGroupLabels': ['Diet as usual and psychoeducation for depression']}, {'name': 'dietary coaching', 'type': 'OTHER', 'description': 'dietary coaching', 'armGroupLabels': ['Mediterranean Diet and dietary coaching']}, {'name': 'Psychoeducation on depression', 'type': 'OTHER', 'description': 'Psychoeducation on depression (50minutes once a week for 4 weeks)', 'armGroupLabels': ['Diet as usual and psychoeducation for depression']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sabrina Mörkl, DDr.', 'role': 'CONTACT', 'email': 'sabrina.moerkl@medunigraz.at', 'phone': '004331638581743'}, {'name': 'Eva Reininghaus, Prof.', 'role': 'CONTACT', 'email': 'eva.reininghaus@medunigraz.at'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}