[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637439":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":41,"locations":47,"responsibleParty":64,"collaborators":31,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":31,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":92,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"GROUP 1: subjects who will take the dietary supplement based on olive leaf extract","EXPERIMENTAL","GROUP 1 (22 subjects) subjects who will have to take the food supplement based on olive leaf extract (Olea europea L.)",[13],"Dietary Supplement: ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT",{"label":15,"type":10,"description":16,"interventionNames":17},"subjects who will take the food supplement based on olive extract and mullein extract","GROUP 2 (22 subjects) subjects who will have to take the food supplement based on olive extract (Olea europea L. folium) and mullein extract (Verbascum thapsus L. herba cum floribus).",[18],"Dietary Supplement: ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT",{"label":20,"type":21,"description":22,"interventionNames":23},"PLACEBO","PLACEBO_COMPARATOR","GROUP 3 subjects who will take placebo",[24],"Other: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT","INGREDIENTS: Olea europea L. - folium extract, dry extract standardized to contain 12% oleuropein; glazing agent: hydroxypropyl methylcellulose (E464); anti-caking agent: magnesium salts of fatty acids (E470b); coloring agent: iron oxides and hydroxides (E172).\n\nDirections for use: Take 2 capsules daily (containing a total of 600 mg of Olea europea dry extract - 72 mg of oleuropein), preferably between meals, with a small amount of water.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT","INGREDIENTS: Olea europea L. - folium extract, dry extract titrated at 12% in oleuropein; Verbascum thapsus L. - herba cum floribus leaf extract, dry extract titrated at 3% in verbascoside; glazing agent: hydroxypropyl methylcellulose (E464); anti-caking agent: magnesium salts of fatty acids (E470b); colouring agent: iron oxides and hydroxides (E172).",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"OTHER","Placebo","The placebo consists of inert excipients and is identical in shape, color, odor, taste, weight, and packaging to the active treatment, thus ensuring blinding.",[20],[42],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Alessandra A Baldi, graduated","CONTACT","+393483854114","alessandra.baldi.alimenti@gmail.com",[48],{"facility":49,"status":31,"city":50,"state":31,"zip":31,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"COMEGEN Soc. Coop. Sociale, Napoli, 80126","Naples","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],14.26811,40.85216,{"lat":57,"lon":56},[60],{"name":61,"role":44,"phone":62,"phoneExt":31,"email":63},"Dott. Claudio Polistina, guaduated","+ 39 081\u002F6174566","comegen@comegen.org",{"type":65,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100637439","study-on-the-effectiveness-and-safety-of-two-olive-extract--based-olea-europea-l-folium-supplements-alone-or-combined-with-a-mullein-extract-verbascum-thapsus-l-herba-cum-floribus-for-the-maintenance-of-cognitive-function-100637439",false,"NCT07586410","Study on the Effectiveness and Safety of Two Olive Extract- Based (Olea Europea L. Folium) Supplements, Alone or Combined With a Mullein Extract (Verbascum Thapsus L. Herba Cum Floribus), for the Maintenance of Cognitive Function.","Efficacy and Tolerability Study of Two Food Supplements, the First Based on an Olive Extract (Olea Europea L. Folium) and the Second on the Combination of the Latter With a Mullein Extract (Verbascum Thapsus L. Herba Cum Floribus), for the Maintenance of Cognitive Function: a Single-center, Randomized, Placebo-controlled, Parallel-arm, Double-blind Clinical Study.","Participants of both sexes who meet the following characteristics will be included in the study:\n\n* aged between 60 and 85 years;\n* able to understand and sign the informed consent form;\n* able to understand and comply with the protocol requirements;\n* negative HIV test;\n* score between 20 and 25 on the Montreal Cognitive Assessment (MoCA) questionnaire (Nasreddine et al., 2005).\n* total Instrumental Activities of Daily Living (IADL) + Activities of Daily Living (ADL) score of 14;\n* Geriatric Depression Scale (GDS) score between 0 and 5;\n* Generalized Anxiety Disorder (GAD-7) score between 0 and 4;\n* not currently taking or taking any medications, including antidiabetics, drugs that affect the nervous system such as antidepressants, anxiolytics, or opioids;\n* who are not taking antibiotics or have not taken antibiotics in the last four weeks, or in the last 6 months, based on the intensity and duration of antibiotic treatment.\n\nSubjects with the following characteristics will be excluded from the study:\n\n* aged \\\u003C 60 and \\> 85 years;\n* individuals with a MoCA questionnaire score \\\u003C 20 and \\> 26;\n* Geriatric Depression Scale (GDS) score \\> 5;\n* Generalized Anxiety Disorder (GAD-7) score \\> 4;\n* who show no willingness to cooperate;\n* who have difficulty traveling to the referral facility on time;\n* who are deemed unsuitable by the investigator due to the presence of other conditions deemed incompatible with enrollment and which require pharmacological treatments (e.g., active systemic diseases, diabetes, neurological and psychiatric conditions, including cognitive disorders that prevent completion of the questionnaires);\n* affected by HIV-acquired immunodeficiency;\n* individuals with severe visual and hearing impairments;\n* with known allergies to ingredients of the investigational products (active or placebo);\n* who abuse alcohol, drugs, nicotine, caffeine, or theine;\n* who take medications.",true,"ALL","60 Years","85 Years",{"count":78,"type":79},99,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if two food supplements based on olive leaf extract, alone or combined with mullein extract, help maintain cognitive function in older adults with mild cognitive impairment (MCI). It will also evaluate their safety. The main questions it aims to answer are:\n\nDo the supplements improve or help maintain cognitive function (such as memory and attention)? Do participants experience any side effects when taking the supplements?\n\nResearchers will compare two active supplements to a placebo (a look-alike substance with no active ingredients) to see if the supplements are effective.\n\nParticipants will:\n\nTake either one of the two supplements or a placebo every day for 6 months Take 2 capsules per day, preferably between meals, with a small amount of water Visit the clinic at the start of the study, after 3 months, and after 6 months for cognitive assessments Complete questionnaires to evaluate cognitive function and quality of life Be monitored throughout the study for any side effects",[85],"Cognition Disorders in Old Age",[87,88,89,90,91],"cognitive decline","elderly people","food supplement","congitive function","preventivon","NOT_YET_RECRUITING","2026-05-08",{"date":95,"type":96},"2026-05-14","ACTUAL",{"date":98,"type":79},"2026-05-05",{"date":100,"type":79},"2026-11",{"name":5,"class":6},1]