[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550245":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":12,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":12,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Passive control group","NO_INTERVENTION","The passive control arm will not receive any intervention and will only be evaluated for primary outcome variables at the beginning (week: 0) and at the end (week: 12) of the protocol.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Active control group","ACTIVE_COMPARATOR","MIND diet will be applied to participants assigned to the active control arm for 12 weeks. This group will be evaluated at visits (week: 0-4-8-12) in terms of primary and secondary outcome variables, in parallel with the intervention group (KD).",[18],"Other: Dietary Intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Intervention group (Modified ketogenic diet)","EXPERIMENTAL","The modified ketogenic diet (MKD) will be applied to participants assigned to the intervention arm for 12 weeks. This group will be evaluated for primary and secondary outcome variables at visits (weeks 0-4-8-12).",[18],[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"Dietary Intervention","The intervention includes the application and follow-up of different diet therapies to individuals (Ketogenic diet and MIND).",[14,20],[30],{"name":31,"affiliation":32,"role":33},"Mehmet I Naharcı, Prof.","Saglik Bilimleri University","STUDY_CHAIR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":12,"email":38},"CONTACT","(+90)3123812350\u002F6578","drnaharci@yahoo.com",{"name":40,"role":36,"phone":12,"phoneExt":12,"email":41},"Hilal Şimşek","hllsimsek@ankara.edu.tr",[43],{"facility":44,"status":45,"city":46,"state":12,"zip":47,"country":48,"countryCode":12,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Gulhane Faculty of Medicine & Gulhane Training and Research Hospital","RECRUITING","Ankara","06010","Turkey (Türkiye)",{"type":50,"coordinates":51},"Point",[52,53],32.85427,39.91987,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":12,"phoneExt":12,"email":38},"Mehmet I Naharci, Prof.",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Mehmet Ilkin Naharci","Prof.",[63],{"name":64,"class":6},"Ankara University","100550245","modified-ketogenic-diet-in-amnestic-mild-cognitive-impairments-100550245",false,"NCT06444568","Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments","Efficacy of Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments","Inclusion Criteria:\n\n* Having been diagnosed with \"amnestic mild cognitive impairment\u002Fdisorder (aMCI)\" by the clinician after the evaluation of cognitive functions according to the neuropsychological evaluation method (0.5 according to the Clinical Dementia Rating Scale (CDR).)\n* Having at least 6 years of education.\n\nExclusion Criteria:\n\n* Under the age of 65 or over the age of 80.\n* Diagnosis of neurological (other than MCI) or psychological diseases.\n* GDS-15 score \\> 5 (baseline)\n* Kidney\u002Fpancreas\u002Fliver diseases or dysfunctions, Type 1 diabetes (and Type II diabetic patients receiving insulin replacement therapy), cancer, metabolic diseases (fatty acid oxidation defect, etc.), thyroid dysfunction, pulmonary or autoimmune diseases, head trauma, history of any cardiovascular event (i.e., stroke, myocardial infarction) in the last year.\n* Hypercholesterolemia (fasting T-C \\>300 mg\u002FdL or LDL-C \\>200 mg\u002FdL), non-reference B12 or folate levels according to biochemical tests performed in the last year.\n* Nutritional risks (chewing\u002Fswallowing difficulties, history of involuntary weight loss in the last 6 months, body mass index \\\u003C 22 kg\u002Fm2).\n* Use of internal device\u002Fimplant (pacemaker or hearing aid, etc.).\n* Medication use (individuals using anticholinergic, antidementia, and opioid class drugs will be excluded; individuals using antidepressant class drugs will be included in the study on the condition that it has been continued for at least 3 months and there is no change in drug type and dose during the study protocol.)","ALL","65 Years","80 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80],"NA","This clinical study aims to examine the effectiveness of a 12-week modified ketogenic diet (MKD) intervention, especially on cognitive functions, in individuals diagnosed with amnestic-mild cognitive impairment (aMCI) and to compare the effects of control groups (passive or active).\n\nAccordingly, a sample of 36 older adults aged 65-80 years diagnosed with aMCI will be randomized into 3 different groups: passive control (without any intervention), active control (MIND: Mediterranean-DASH Intervention for Neurodegenerative Delay diet) or intervention (MKD). They will be monitored according to targeted criteria throughout the 12-week study protocol.\n\nThe main questions this study aims to answer are:\n\n* Does a 12-week MKD intervention improve cognitive functions in aMCI?\n* Does the effectiveness of the 12-week MKD intervention in aMCI (i.e., in terms of cognitive function, physical and functional measures, or metabolic\u002Finflammatory biomarkers) differ from control groups?\n\nExpected from participants during the study protocol:\n\n* Participants assigned to the passive control arm are expected to come to the research center at the beginning (week 0) and end (week 12) of the protocol and participate in evaluations.\n* Participants assigned to the active control (MIND diet) or intervention (MKD) arm are expected to adhere to assigned dietary therapy, keep a weekly food diary, and have weekly phone calls or online meetings with the dietitian to follow up on the diet. These participants assigned to the diet groups are expected to come to the research center at weeks 0, 4, 8, and 12 to participate in the evaluations.",[83,84],"Amnestic Mild Cognitive Disorder","Amnestic Mild Cognitive Impairment","2024-11-20",{"date":87,"type":88},"2024-11-25","ACTUAL",{"date":90,"type":88},"2024-05-20",{"date":92,"type":77},"2025-03-01",{"name":5,"class":6},1]