[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648017":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":61,"collaborators":23,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":93,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy subjects","ACTIVE_COMPARATOR","Three consecutive high-fat vitamin E-stripped meals",[13],"Dietary Supplement: High fat liquid shake",{"label":15,"type":16,"description":11,"interventionNames":17},"Subjects with hyperlipidemia","EXPERIMENTAL",[13],[19],{"type":20,"name":21,"description":11,"armGroupLabels":22,"otherNames":23},"DIETARY_SUPPLEMENT","High fat liquid shake",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Robert D Shamburek, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Katherine C Roskom, R.N.","CONTACT","(301) 451-7094","katherine.roskom@nih.gov",{"name":26,"role":32,"phone":36,"phoneExt":23,"email":37},"(301) 496-3460","bobs@mail.nih.gov",[39],{"facility":40,"status":23,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.10026,38.98067,{"lat":50,"lon":49},[53,56],{"name":54,"role":32,"phone":55,"phoneExt":23,"email":37},"Robert Shamburek, M.D.","301-496-3460",{"name":57,"role":32,"phone":58,"phoneExt":59,"email":60},"NIH Clinical Center Office of Patient Recruitment (OPR)","(800) 411-1222","TTY dial 711","ccopr@nih.gov",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100648017","plasma-lipids-dependent-vitamin-e-metabolism-during-dynamic-hyperlipidemia-100648017",false,"NCT07715890","Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","* INCLUSION CRITERIA\n\nCohort 1\n\n1. Males and females between the ages of 18 to 65\n2. BMI 18.5 - 26.9 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations\n4. Normotensive, not on medications for hypertension\n5. Not on glucose-lowering or lipid-lowing medications\n6. Screening labs with baseline HbA1c \\\u003C5.7%, baseline fasting triglyceride \\\u003C 150 mg\u002FdL and LDL \\\u003C100 mg\u002FdL\n7. Liver fat \\\u003C2%\n\nCohort 2\n\n1. Males and females between the ages of 18 to 65\n2. BMI \\>26 kg\u002Fm\\^2 and \\\u003C36 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.\n4. Screening labs with baseline HbA1c \\\u003C= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride \\\u003C 500 mg\u002FdL and LDL \\\u003C190 mg\u002FdL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.\n5. Liver fat \\\u003C2%\n\nEXCLUSION CRITERIA\n\n1. For women: pregnancy or currently breastfeeding\n2. Subjects \\\u003C18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects.\n3. Subjects \\>65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals.\n4. Heavy alcohol user (males with \\>2 drinks per day or \\>14 drinks per week; female with \\>1 drinks per day or \\>7 drinks per week)\n5. Current smoker, or former smoker who quit smoking \\\u003C15 years ago\n6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months\n7. Subjects with lactose intolerance unwilling to take lactase\n8. Subjects with type 1 diabetes\n9. Subjects with hemoglobin \\\u003C11 g\u002FdL or hematocrit \\\u003C33%\n10. Subjects with abnormal liver function test results\n11. Subjects with liver fat \\>= 2% on abdominal MRI\n12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases\n13. Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism\n14. Subjects on glucocorticoids \\>1 week (not including topical glucocorticoids)\n15. Subjects with HIV\n16. Subjects with uncontrolled psychiatric and\u002For behavioral disorders\n17. Subjects taking diabetes medications other than metformin\n18. Anticipated surgery during the study period\n19. Subjects with severe medication-resistant claustrophobia\n20. Subjects who are unwilling to stop medications, vitamins and\u002For dietary supplements that investigators have requested to be held\n21. Subjects participating in any other clinical study without informing investigators\n22. Any other reason or clinical condition that the investigators judge would interfere with study participation and\u002For be unsafe for a participant or staff member","ALL","18 Years","65 Years",{"count":74,"type":75},48,"ESTIMATED","INTERVENTIONAL",[78],"NA","Background:\n\nObesity is known to lead to diseases such as diabetes and high cholesterol (or fats) in the blood (hyperlipidemia). But no one knows why. Researchers think that high levels of fat in the blood may block important nutrients, such as vitamin E, from reaching places they are needed in the body.\n\nObjective:\n\nTo learn how high-fat meals affect levels of vitamin E in the blood.\n\nEligibility:\n\nPeople aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.\n\nParticipants will be screened. They will have a physical exam and blood tests.\n\nAfter this visit, all participants must stop taking any dietary supplements.\n\nThose who use them must also stop taking any drugs to lower their blood sugar and blood fats. These participants will have an extra visit for blood tests after 60 days.\n\nThe next visit will include 2 imaging scans:\n\nMagnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.\n\nDual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.\n\nOn day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.\n\nOn day 2, they will drink high-fat shakes at 8 am, noon, and 4 pm. They will have blood draws every hour for 17 hours, and then every 2 hours until 7 am. The blood will be taken from a tube inserted into a vein and left in place for the day.\n\nOn day 3, they will go home.",[81],"Lipid Metabolism Disorders",[83,84,85,86,87,88,89,90,91,92],"Vitamin E","Vitamin K","Vitamin D","Vitamin C","Postprandial","Fat meal","Sequestration","Hypertriglyceridemia","Fat-Soluble Vitamins","gamma tocopherol","NOT_YET_RECRUITING","2026-08-20",{"date":96,"type":97},"2026-08-21","ACTUAL",{"date":99,"type":75},"2026-08-26",{"date":101,"type":75},"2029-03-31",{"name":27,"class":6},1]