[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ketosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ketosis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,75,98,123,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100578178","phase-2-effects-of-ketones-on-brain-energetics-and-alcohol-consumption-in-alcohol-use-disorder-100578178",false,"NCT06807918","Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder","Effects of Ketone Supplementation on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder","KABA","Inclusion Criteria:\n\n1. Age 21-65 years old\n2. Able to provide written informed consent\n3. Meets current DSM-5 criteria for mild to moderate (established using MINI)\n4. Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)\n5. Not seeking treatment for AUD (self-report)\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).\n2. Use of psychoactive medications or medications that may affect study results (self-report, medical history).\n3. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year.\n4. Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).\n6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.\n7. Clinically significant laboratory findings that could affect brain function (e.g., HIV+).\n8. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).\n9. Pregnant or breast-feeding\n10. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).\n11. BMI greater than 35.\n12. Self-reported claustrophobia.\n13. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).","ALL","21 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET\u002FCT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.",[29,30],"Alcohol Use Disorder","Ketosis",[29,30,32,33],"Ketone supplement","Magnetic Resonance Spectroscopy","NOT_YET_RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":22},"2026-08-01",{"date":42,"type":22},"2030-01-01",{"name":44,"class":45},"University of Pennsylvania","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100510273","variations-in-ketone-metabolism-100510273","NCT05924295","Variations in Ketone Metabolism","Strategies to Augment Ketosis- Variations in Ketone Metabolism","STAK-VKM","Inclusion Criteria:\n\n* Ages 20 - 70 years\n* Participant is willing and able to comply with all study procedures including the following prior to Test Day: fasting (\\>10 h; water only), no alcohol (\\>24 h), no exercise (\\>24 h), no acute illness and controlled feeding before the Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.\n* Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.\n* Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.\n\nExclusion Criteria:\n\n* Participant follows a low-carbohydrate diet (\\\u003C30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation.\n* Participant has a Primary Care Physician diagnosed history or presence of uncontrolled and\u002For clinically important hypertension (blood pressure \\>150\u002F95 mmHg), pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and\u002For anxiety disorders) or biliary disorders.\n* Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein, wheat, shellfish, fin fish, eggs, tree nuts or peanuts (production facility handles nuts).\n* Participant has unstable use of a medication or supplement that the Investigator considers may affect the outcomes of the trial.\n* Consumption of alcohol more than 3 drinks per day or more than 18 drinks per week.\n* Consumption of tobacco.\n* Consumption of cannabis.\n* Participant is currently in another research study or has been in the 14 days before screening.\n* Participant has had a blood draw or donation in the last 8 weeks.\n* Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage \\[e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, medication managed reflux and\u002For clinically important lactose intolerance\\].\n* Participant has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.",true,"20 Years","70 Years",{"count":59,"type":22},400,[61],"NA","This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health",[30],"RECRUITING","2026-05-12",{"date":67,"type":38},"2026-05-14",{"date":69,"type":38},"2023-06-20",{"date":71,"type":22},"2027-01-01",{"name":73,"class":45},"Ohio State University",2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100578741","phase-2-effects-of-ketone-supplement-and-alcohol-on-brain-metabolism-100578741","NCT06815237","Effects of Ketone Supplement and Alcohol on Brain Metabolism","Acute Effects of Ketone Supplementation and Alcohol on Brain Metabolism","Inclusion Criteria:\n\n1. Able to provide written informed consent and commit to completing study procedures.\n2. Reported on at least one day in the month before consent of consuming 2 or more standard alcoholic drinks on a single day.\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from the use of psychoactive medications, medication that may affect study results, and or alcohol, within 24 hours of the Alcohol lab, and MRI procedures (self-report, medical history, UDS, and breathalyzer).\n2. Current DSM-5 diagnosis of a major psychiatric disorder (other than marijuana and nicotine use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.\n3. Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; psychotropic drugs not otherwise specified)\n4. Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).\n6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.\n7. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).\n8. Pregnant or breast-feeding\n9. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).\n10. Self-reported claustrophobia\n11. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).",{"count":21,"type":22},[25,26],"The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention. These interventions will be randomly assigned (meaning everyone receives all 3 interventions, but in different orders).",[30,86,87],"Alcohol Drinking","MRI",[89],"ketone supplement","2026-03-23",{"date":92,"type":38},"2026-03-25",{"date":94,"type":38},"2025-05-13",{"date":96,"type":22},"2029-05-31",{"name":44,"class":45},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":46},"100559120","phase-2-effects-of-ketone-supplementation-on-alcohol-withdrawal-and-brain-metabolism-in-alcohol-use-disorder-100559120","NCT06559995","Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder","KSAW","Inclusion Criteria:\n\n1. Able to communicate English and provide written informed consent\n2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD\n3. Minimum 3-year history of heavy drinking (self-report).\n4. Presence of alcohol withdrawal (DSM-5)\n\nExclusion Criteria:\n\n1. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.\n2. Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam.\n3. Clinically significant laboratory findings that could affect brain function (e.g., HIV+)\n4. Head trauma with loss of consciousness for more than 30 minutes,\n5. Pregnant or breast-feeding\n6. BMI greater than 35\n7. Self-reported claustrophobia\n8. Contraindications to MRI (e.g., metal in the body that cannot be removed).\n9. Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.\n10. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results\u002Fwithdrawal management plan.\n11. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.","18 Years",{"count":107,"type":22},30,[25,26],"The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.",[29,111,30],"Alcohol Withdrawal",[29,111,113,114],"ketosis","Ketone Supplement","2025-09-08",{"date":117,"type":38},"2025-09-15",{"date":119,"type":38},"2025-08-01",{"date":121,"type":22},"2027-12",{"name":44,"class":45},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":46},"100573643","ketogenic-metabolic-therapy-in-schizophrenia-bipolar-disorder-major-depressive-disorder-deep-omic-profiling-100573643","NCT06748950","Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling","A Randomized Controlled Trial of a Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling","Inclusion Criteria:\n\n1. diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia\n\n   1. For individuals diagnosed with bipolar disorder (BD):\n\n      * Meet DSM V criteria for BD (any subtype)\n      * Not mild\n      * \\>40 on BPRS\n      * clinically stable (with no hospitalization for past 3 months)\n   2. For individuals diagnosed with major depressive disorder (MDD):\n\n      * Not mild\n      * PHQ-9 \\> 10\n      * clinically stable (with no hospitalization for past 3 months)\n   3. For individuals diagnosed with schizophrenia:\n\n      * Meet DSM V criteria for schizophrenia (any subtype)\n      * Not mild\n      * \\>40 on BPRS\n      * clinically stable (with no hospitalization for past 3 months)\n2. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medication. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable. Participants may be switched from other classes of medication to another medication class by their psychiatrist or primary care doctor, but need to be stable enough to enroll and adhere to study procedures.\n3. willing and able to give informed consent for participation in English.\n4. live within the United States.\n\n   \\--------------------------------------------------------------------------------\n\nExclusion Criteria:\n\n1. has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll\n2. pregnant or nursing\n3. insulin dependent\n4. comorbidity of developmental delay\n5. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary programs.\n6. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months\n7. inability to complete baseline measurements\n8. severe renal or hepatic insufficiency\n9. cardiovascular dysfunction, including diagnosis of:\n\n   * Congestive heart failure\n   * Angina\n   * Arrhythmias\n   * Cardiomyopathy\n   * Valvular heart disease\n10. active substance abuse with illicit drugs or alcohol and\u002For current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine or cannabis dependence\n11. active suicidal and considered at significant risk for suicide during course of study\n12. participation in any clinical trial- within the past month or concurrent to study participation- with an investigational drug\u002Fdevice and\u002For intervention that may interfere with study participation\u002Fevaluation of results\n13. mild BPRS at screening or baseline visits\n14. history of TBI\n15. any other medical condition that may make diet intervention dangerous as determined by the study medical team (e.g. anorexia nervosa) or assessed by study team to have insufficient control over their food intake to adhere to study diets.\n16. any medical condition that physicians or the PI believe would interfere with study participation or evaluation of results\n17. history of familial hypercholesterolemia","80 Years",{"count":132,"type":22},120,[61],"The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.",[136,137,138,139,140,141,142,30,143,144],"Schizophrenia","Schizophrenia and Related Disorders","Bipolar Disorder","Bipolar and Related Disorders","Major Depressive Disorder","Major Depression Severe","Ketogenic Dieting","Metabolic Disease","Metabolic Syndrome",[146,147,148,149],"Mental Illness","Multiomics","Multi-omics","Omics Profiling",{"date":151,"type":38},"2025-05-16",{"date":153,"type":22},"2025-07",{"date":155,"type":22},"2028-07",{"name":157,"class":45},"Stanford University",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":46},"100582758","effects-of-exogenous-ketosis-on-proteinuria-and-renal-function-100582758","NCT06867471","Effects of Exogenous Ketosis on Proteinuria and Renal Function","Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease","KETO-CKD","Inclusion Criteria\n\nStudy A (patients with CKD):\n\n* ACR \\> 200 mg\u002Fg \\\u003C3000 mg\u002Fg\n* eGFR \\>30 ml\u002Fmin\u002F1,73m2\n* Treatment with Renin-Angiotension System (RAS) blockers and SGLT-2 inhibitors for a minimum of 4 weeks prior to inclusion\n* Safe contraception if women in childbearing age\n\nStudy B (patients with PKD):\n\n* Prior diagnose with PKD\n* eGFR \\>30 ml\u002Fmin\u002F1,73m2\n* Treatment with Renin-Angiotension System (RAS) blockers for a minimum of 4 weeks prior to inclusion\n* Safe contraception if women in childbearing age\n\nExclusion Criteria (Study A+B)\n\n* Diabetes Mellitus type 1\n* Heart Failure\n* Liver Disease\n* Kidney transplant\n* Malignant diseases (except skin cancer)\n* Recent acute myocardial infarction (AMI), apoplexia\u002Ftransient ischemic attack (TIA) (within 3 months of inclusion)\n* Pregnancy or breast feeding\n* Alcohol or drug abuse\n* Periodic fasting within four weeks of inclusion\n* Routinely intake of ketogenic diet within four weeks of inclusion\n* Treatment with nitrate",{"count":167,"type":22},43,[61],"A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.",[171,172,173,30],"Renal Insufficiency, Chronic","Polycystic Kidney Diseases","Proteinuria",[175,176,177,30,173,178],"Kidney physiology","Glomerular Filtration Rate","Chronic Kidney disease","Natriuresis","2025-03-06",{"date":181,"type":38},"2025-03-10",{"date":183,"type":38},"2024-09-11",{"date":185,"type":22},"2025-12",{"name":187,"class":45},"Gødstrup Hospital"]