[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634955":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":61,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketone","EXPERIMENTAL",null,[13],"Dietary Supplement: Ketone Monoester (KE)",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","Ketone Monoester (KE)","The intervention is a single acute oral dose of a commercially available ketone monoester supplement (DeltaG®, Oxford, England). The active ingredient, (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, is rapidly metabolized after ingestion to raise circulating beta-hydroxybutyrate concentrations without requiring dietary carbohydrate restriction or fasting. The supplement is administered under supervised conditions during a study visit. Brain imaging with fluorodeoxyglucose F18 positron emission tomography combined with magnetic resonance imaging is performed during the post-ingestion period while participants complete a cognitive processing speed task. This protocol evaluates the immediate metabolic and neurocognitive effects of exogenous ketone administration within a single session.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"The placebo consists of a taste-, color-, and volume-matched beverage formulated to mimic the sensory characteristics of the ketone monoester supplement but containing no active ketone ingredient. The placebo does not contain (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) and does not elevate circulating beta-hydroxybutyrate concentrations.\n\nThe placebo beverage will be administered orally under supervised research conditions during a study visit using procedures identical to the active supplement condition. Brain imaging with fluorodeoxyglucose F18 positron emission tomography combined with magnetic resonance imaging will be performed during the post-ingestion period while participants complete a cognitive processing speed task. This control condition allows isolation of the metabolic effects of ketone elevation from expectancy or beverage-related effects.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Katherine Sweatt, PhD","CONTACT","205-975-5398","sksweatt@uab.edu",[35,52],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UAB Comprehensive Cancer Center","RECRUITING","Birmingham","Alabama","35205","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.80249,33.52066,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":32,"phoneExt":11,"email":33},"Sarah K Sweatt, PhD",{"facility":53,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Webb Nutrition Sciences Building",{"type":44,"coordinates":55},[46,47],{"lat":47,"lon":46},[58,59],{"name":51,"role":31,"phone":32,"phoneExt":11,"email":33},{"name":51,"role":60,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Katherine Sweatt","Scientist I","100634955","effects-of-exogenous-ketones-on-cognitive-function-in-older-adults-with-prediabetes-100634955",false,"NCT07546409","Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?","Can Exogenous Ketone Supplementation Compensate for Glucose Hypometabolism and Improve Cognitive Processing Speed in Veterans With Prediabetes?","Inclusion Criteria:\n\n* Age 60 to 75 years\n* Able to provide written informed consent\n* Fluent in English\n* No diagnosed cognitive impairment or dementia\n\nClassified as either:\n\n* Prediabetes (based on American Diabetes Association criteria), or Normal glucose regulation (control group)\n* Medically stable and cleared to undergo positron emission tomography and magnetic resonance imaging\n* Willing to comply with study procedures, including metabolic testing, supplement ingestion, and neuroimaging\n\nExclusion Criteria:\n\n* Diagnosis of mild cognitive impairment, dementia, or other neurodegenerative disorder\n* Diagnosis of type 1 diabetes or type 2 diabetes\n* Use of glucose-lowering medications (e.g., insulin, metformin, glucagon-like peptide-1 receptor agonists)\n* History of major neurological disorder (e.g., stroke, traumatic brain injury with loss of consciousness \\>30 minutes, epilepsy, multiple sclerosis)\n* Major psychiatric disorder not stable on treatment\n* Uncontrolled hypertension or significant cardiovascular disease\n* Severe renal, hepatic, or gastrointestinal disease that may affect supplement metabolism\n* Contraindications to magnetic resonance imaging (e.g., non-compatible implanted devices, severe claustrophobia)",true,"ALL","60 Years","75 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"NA","Brief Summary\n\nThe goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in brain energy use and thinking speed compared to older adults with normal blood sugar levels. The study will also test whether a single dose of an exogenous ketone supplement can improve brain energy use and cognitive processing speed.\n\nThe main questions it aims to answer are:\n\nDo older adults with prediabetes have lower brain glucose uptake and slower cognitive processing speed compared to those with normal glucose levels?\n\nDoes a single dose of an exogenous ketone monoester supplement improve cognitive processing speed and brain glucose uptake?\n\nResearchers will compare older adults with prediabetes to older adults with normal glucose levels to determine whether differences exist in brain glucose metabolism and cognitive performance. In a subset of participants, researchers will also compare brain and cognitive outcomes before and after consuming a ketone monoester supplement (DeltaG, Oxford, England).\n\nParticipants will:\n\nComplete metabolic testing to determine glucose status\n\nUndergo brain imaging using fluorodeoxyglucose positron emission tomography combined with magnetic resonance imaging (18FDG-PET\u002FMRI) while performing a cognitive processing speed task\n\nConsume a single dose of a commercially available ketone monoester supplement during one study visit\n\nComplete cognitive testing during imaging to measure processing speed and brain activity\n\nThe results of this study will help determine whether early metabolic dysfunction is linked to reduced brain energy use and whether ketones can temporarily support brain function in individuals at risk for dementia.",[83,84],"Prediabetes","Healthy (Controls)",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101],"Prediabetic State","Insulin Resistance","Brain Glucose Metabolism","Cerebral Glucose Uptake","Fluorodeoxyglucose F18","Positron-Emission Tomography","Magnetic Resonance Imaging","Functional Magnetic Resonance Imaging","Cognitive Dysfunction","Dementia","Aging","Processing Speed","Ketone Bodies","beta-Hydroxybutyrate","Neuroimaging","Brain Energy Metabolism","2026-06-30",{"date":104,"type":105},"2026-07-02","ACTUAL",{"date":107,"type":105},"2025-05-20",{"date":109,"type":77},"2027-05-31",{"name":5,"class":6},2]