[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522355":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic Diet","EXPERIMENTAL","This arm will be provided food to induce a state of nutritional ketosis in each person as defined as blood Beta-hydroxybutyrate (3-OHB) ≥0.5 millimoles (mM), which will require most participants to consume \\\u003C50 g\u002Fday carbohydrate and 1.5g\u002Fkg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.",[13],"Dietary Supplement: Ketogenic diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-fat mixed Diet","This arm will be provided food consisting of \\~25% fat, and the remaining calories from carbohydrate (\\~55% after accounting for protein at \\~20%).",[18],"Dietary Supplement: Low-fat Mixed diet",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Ketogenic diet","Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff for the first 6 weeks. After that will be a free-living diet period where food will not be supplied but participants will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Participants will be asked to exclusively follow the diet in efforts to control any dietary effects.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Low-fat Mixed diet",[15],[30],{"name":31,"affiliation":5,"role":32},"Yuchi Han, MD, MMSc","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Debbie Scandling, BS","CONTACT","614-688-5623","debbie.scandling@osumc.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Alyssa Marie Castillo, MS","614-688-1213","alyssamarie.castillo@osumc.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The Ross Heart Hospital","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-82.99879,39.96118,{"lat":56,"lon":55},[59,60,61,64],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Orlando Simonetti, Ph.D.","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":25,"phoneExt":25,"email":25},"Jeff Volek, Ph.D.",{"type":32,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Yuchi Han","Professor-Clinical, Cardiovascular Medicine",[70],{"name":71,"class":72},"United States Department of Defense","FED","100522355","ketogenic-diet-vs-mixed-diet-in-patients-with-heart-failure-100522355",false,"NCT06081543","Ketogenic Diet vs Mixed Diet in Patients With Heart Failure","A Prospective Randomized Unblinded Study of Ketogenetic Versus Mixed Diet on Exercise Tolerance in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction","Inclusions:\n\n1. Age ≥ 18 years old and ≤ 80 years old \\& willingness to be randomized to either diet.\n2. NYHA class I - III for at least 3 months.\n3. Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR\n4. Echo findings of abnormal or indeterminant diastolic function or right heart catheterization (RHC) data: At rest: mean pulmonary capillary wedge pressure (PCWP) \\> 15 mmHg. pulmonary vascular resistance (PVR) \\\u003C 3 Wood Units.\n5. Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or during enrollment and dosage should be stable for 1 month prior to enrollment).\n6. Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization.\n7. Body Mass Index (BMI) ≥ 25 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg\u002FdL or glycated hemoglobin (A1C) 5.7-6.4% or metabolic syndrome.\n8. Ability to participate in exercise treadmill testing.\n9. Ability to sign written consent.\n\nExclusions:\n\n1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study.\n2. Known allergy or sensitivity to gadolinium-based contrast agents.\n3. Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist device.\n4. Other metallic implants\u002Faneurysm clips that are contraindicated in MRI.\n5. Claustrophobia\n6. History of severe kidney disease of estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fkg\u002F1.73m2.\n7. Type I diabetes.\n8. History of diabetic ketoacidosis.\n9. Prior diagnosis of oxygen dependent pulmonary disease.\n10. Body Mass Index (BMI) \\\u003C 25.\n11. Recent acute myocardial infarction or acute coronary syndrome (30 days).\n12. Or recent (within 30 days) or planned (within 30 days) cardiac revascularization History of left main disease, severe triple vessel disease, coronary artery bypass graft surgery.\n13. Left ventricular ejection fraction \\\u003C 50%.\n14. Uncontrolled systemic systolic blood pressure (SBP)\u002Fdiastolic blood pressure (DBP) hypertension (SBP \\>180 or DBP \\>110 mmHg).\n15. Severe stenotic or regurgitant valvular heart disease, expected to lead to surgery during the study period.\n16. Persistent atrial fibrillation.\n17. History of uncontrolled or untreated ventricular arrhythmias.\n18. Cardiovascular diseases or treatments that increase the unpredictability of or change the subject's clinical course, independent of heart failure.\n19. Heart transplant or listing for heart transplant.\n20. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction.\n21. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents or mechanical support within 1 week of screening and during the screening period prior to randomization.\n22. Hemoglobin of \\\u003C9 g\u002FdL at screening.\n23. Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening.\n24. Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening.\n25. Gastrointestinal surgery or gastrointestinal disorder that might interfere with diet. Prior bariatric surgery allowed if weight-stable for past 3 months.\n26. Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \\\u003C10 ng\u002FmL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a).\n27. Presence of any disease other than heart failure that results in a life expectancy of \\\u003C1 year (in the opinion of the investigator).\n28. History or recurrent severe hypokalemia, potassium \\\u003C 3.0 mg\u002FdL.\n29. Current enrollment or completion within 30 days of an investigational device or drug study.\n30. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfill the study requirements or complete the trial.\n31. Any other clinical condition that might jeopardize subject safety during participation in this study or prevent the subject from adhering to the study protocol.\n32. Unable or unwilling to follow guidelines of assigned diet group, including inability to purchase food.\n33. Unable to participate in the comprehensive diet program, including biometric data acquisition and data entry.\n34. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.\n35. Patient has to have stable weight over the past 3 months (± 5% total body weight). If no weight was recorded in the past 3 months, will have 1 month lead in time for wash out.\n36. Refusal to consent.","ALL","18 Years","80 Years",{"count":84,"type":85},90,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study is being done to evaluate the effects of a low carbohydrate ketogenic diet (KD) versus a low-fat diet (MD) on exercise tolerance in participants with heart failure with normal pumping function and diabetes or pre-diabetes, or metabolic syndrome, or obesity.",[91],"Heart Failure With Preserved Ejection Fraction",[9,93],"Heart Failure","2026-07-22",{"date":96,"type":97},"2026-07-23","ACTUAL",{"date":99,"type":97},"2023-05-19",{"date":101,"type":85},"2026-08-31",{"name":5,"class":6},1]