[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Food supplement to be taken once a day.",[13],"Dietary Supplement: B-salicornia",{"label":15,"type":16,"description":17,"interventionNames":18},"Clinical practice","NO_INTERVENTION","Without intervention",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","B-salicornia","Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"CRISTINA LÓPEZ AZCÁRATE","CONTACT","+34608114878","Salacunar@gmail.com",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":30},"CARMEN DOMÍNGUEZ RUIZ",[34],{"facility":35,"status":36,"city":37,"state":18,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hospital Universitario Virgen Macarena","RECRUITING","Seville","41009","Spain","ES",{"type":42,"coordinates":43},"Point",[44,45],-5.97317,37.38283,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":29,"phoneExt":18,"email":30},"HOSPITAL UNIVERSITARIO VIRGEN MACARENA",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53],{"name":54,"class":55},"Joan Montaner Villalonga","UNKNOWN","100620115","a-multicenter-randomized-clinical-trial-compared-with-standard-clinical-practice-to-evaluate-the-efficacy-of-a-polyphenol-rich-salicornia-extract-in-the-progression-of-cognitive-decline-in-a-cohort-of-patients-with-lacunar-infarcts-salacunar-100620115",false,"NCT07353424","A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts (SALACUNAR)","A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts","SALACUNAR","Inclusion Criteria:\n\n\\- Patients with lacunar ischemic stroke, confirmed by cranial magnetic resonance imaging performed within the year prior to inclusion, who have an mRS of 3 or less at the time of inclusion will be included (independent patients or those who require assistance with walking). The inclusion age will be between 40 and 90 years.\n\nExclusion Criteria:\n\n* Consumption of vitamin supplements or polyphenol supplements within 30 days prior to inclusion\n* Hyperthyroidism\n* mRS \\>3, serious illness, or expected life expectancy \\\u003C12 months\n* Dysphagia preventing intake of the study capsules\n* Allergies or intolerance to halophytes\n* Pregnant or breastfeeding\n* Active neoplasia\n* Participation in another study","ALL","40 Years","90 Years",{"count":68,"type":69},300,"ESTIMATED","INTERVENTIONAL",[72],"NA","SALACUNAR (LACI-2-polyphenols) is a multi-center randomized controlled trial (RCT) to evaluate the effect of a polyphenol-rich supplement on small vessel neurovascular disease. Specifically, the compound to be tested is a dietary supplement based on Salicornia extract and B vitamins (B-salicornia), which in previous studies has demonstrated a good safety profile and consistent effects in reducing homocysteine levels and improving cognitive outcomes (MOCA) in patients with lacunar infarcts. This has been used to calculate the sample size based on these endpoints. Considering an intragroup variability of the treatment groups (sigma) of 6.07, and accepting an alpha risk of 0.05, a sample of 150 patients per group would achieve a 1-beta statistical power greater than 0.8 in a two-tailed test for differences between means of at least two points on the MOCA scale.\n\nThree hundred patients with lacunar infarcts diagnosed within the last year and confirmed by MRI performed as part of routine clinical practice will be included.\n\nWe will administer 500 mg\u002F24 h of the dietary supplement B-Salicornia for six months (or the control group will be managed according to routine clinical practice) following a PROBE design.\n\nRoutine blood tests will be performed pre- and post-treatment, with routine vascular parameters such as lipids and homocysteine, as well as baseline and six-month assessments of neuropsychological and gait scales.",[75],"Lacunar Stroke",[77,78,79],"attack","food supplement","cognition","2026-01-19",{"date":82,"type":83},"2026-01-20","ACTUAL",{"date":85,"type":83},"2025-06-01",{"date":87,"type":69},"2026-12-31",{"name":5,"class":6},1]