protocolSection identificationModule nctId: NCT06331247, orgStudyIdInfo id: 20230520-2, briefTitle: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia., conditionsModule conditions: Dementia, conditions: Stroke, conditions: Cognitive Change, conditions: Cerebrovascular; Disorder, Thrombotic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcome assessors will be masked from the assignment of the participants., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: General dietary advice, interventions name: Localized MIND diet intervention, interventions name: Routine medical care, outcomesModule primaryOutcomes measure: Change in global cognitive function, primaryOutcomes measure: Change in MIND diet score, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA) score, secondaryOutcomes measure: Change in Mini-Mental State Examination (MMSE) score, secondaryOutcomes measure: Change in brain MRI markers, secondaryOutcomes measure: Change in memory function, secondaryOutcomes measure: Change in language function, secondaryOutcomes measure: Change in executive function, secondaryOutcomes measure: Change in visuospatial function, otherOutcomes measure: Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL), otherOutcomes measure: Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL), otherOutcomes measure: Change in depressive status measured using the Patient Health Questionnaire (PHQ-9), otherOutcomes measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7), otherOutcomes measure: Changes in plasma metabolic profiles measured using metabolome analysis, otherOutcomes measure: Changes in plasma inflammatory biomarker panel, otherOutcomes measure: Changes in the intestinal microbiome, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310058, country: China, contacts name: Lusha Tong, PhD, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False