[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556114":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":34,"interventions":47,"overallOfficials":60,"centralContacts":65,"locations":73,"responsibleParty":92,"collaborators":23,"id":95,"slug":23,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":23,"enrollmentInfo":104,"targetDuration":23,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":76,"whyStopped":23,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Distribuidora Biolife SA de CV","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Cognitive status assessment","Cognitive status assessment using the Mini-Mental State Examination, which ranges from 0 to 30 points and the higher score is better with higher cognition","Assessed at baseline, 3, and 6 months.",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Patients' fatigue status","Evaluation using the 9-item Fatigue Severity Scale, which measures the severity of fatigue and its impact on the daily activities and lifestyle of patients. The scale ranges from 9 to 63 points and the higher the score, the worse the feeling of fatigue",{"measure":18,"description":19,"timeFrame":12},"Selective attention and processing speed","Selective attention and processing speed will be evaluated using the Trail Making Test (TMT), where the average time for TMT Part A is 29 seconds, with more than 78 seconds being considered deficient. For TMT Part B, the average time is 75 seconds, and more than 273 seconds is considered deficient.",{"measure":21,"description":22,"timeFrame":12},"Frailty","Frailty will be assessed using the Fried Frailty Criteria (Phenotype Model), which comprises five criteria. Based on these criteria. 0 criteria = No frailty; 1 to 2 criteria = Pre-frailty; 3 or more criteria = Frailty",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"TRIPLE",[31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"NANO-PSO","EXPERIMENTAL","640 mg of NANO-PSO (pomegranate seed oil)",[40],"Dietary Supplement: NANO-PSO (pomegranate seed oil)",{"label":42,"type":43,"description":44,"interventionNames":45},"Mineral oil","PLACEBO_COMPARATOR","640 mg of mineral oil",[46],"Dietary Supplement: Placebo",[48,56],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DIETARY_SUPPLEMENT","NANO-PSO (pomegranate seed oil)","NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.",[36],[54,55],"Granagard","Omega 5",{"type":49,"name":57,"description":58,"armGroupLabels":59,"otherNames":23},"Placebo","Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.",[42],[61],{"name":62,"affiliation":63,"role":64},"Alejandro Padilla Isassi, Geriatrician and researcher","Distribuidora Biolife S.A. de C.V.","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":23,"email":69},"CONTACT","+525589510727","alejandropadillaisassi@gmail.com",{"name":71,"role":67,"phone":68,"phoneExt":23,"email":72},"Abraham Samra Saad, Geriatrician and researcher","abrahamsamra@gmail.com",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520","RECRUITING","Miguel Hidalgo","Mexico City","11520","Mexico","MX",{"type":83,"coordinates":84},"Point",[85,86],-99.20024,19.43411,{"lat":86,"lon":85},[89],{"name":90,"role":67,"phone":91,"phoneExt":23,"email":69},"Alejandro Padilla Isassi, Geriatrician","5625592234",{"type":64,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Alejandro Padilla Isassi","Principal researcher of the geriatrics area","100556114",false,"NCT06520878","Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment","Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment","COGMEG5","Inclusion Criteria:\n\n* Patients attended at the Hospital Español.\n* Patients of any gender who are 60 years or older.\n* Patients presenting with mild to moderate cognitive impairment.\n* Meet the diagnostic criteria for \\"probable dementia\\" of the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011).\n* Meet the criteria for the typical variant of Alzheimer's disease, specifically a specific clinical phenotype.\n* Progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months.\n* Objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for AD.\n* Subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program.\n* Total score on the Hachinski Ischemic Scale (HIS) ≤ 4.\n* Patients who sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with known allergy to any component of the NANO-PSO capsule (e.g., fish).\n* Patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption.\n* Patients in palliative care with a life expectancy of less than 6 months according to the NECPAL scale.\n* Patients with terminality criteria established in the comprehensive palliative care management guide of Mexico.","ALL","60 Years",{"count":105,"type":106},60,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are:\n\n• Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo?\n\nThe researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients.\n\nParticipants will be required to:\n\n* Consume two capsules of NANO-PSO or placebo daily in the morning for six months.\n* Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment.\n* Be evaluated in person at 90 and 180 days of treatment.\n* The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions.\n* At the end of the final patient evaluation, a quality questionnaire will be administered.",[112],"Cognition",[36,55,114,115,116],"Supplementation","Cognitive impairment","Antioxidants","2025-02-03",{"date":119,"type":120},"2025-02-06","ACTUAL",{"date":122,"type":106},"2025-02-12",{"date":124,"type":106},"2025-12-01",{"name":5,"class":6},1]