[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715890":3,"trial-entities:NCT07715890":107,"trial-summary:NCT07715890":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":46,"secondary_outcomes":51,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":87,"overall_officials":95,"references":98,"see_also_links":103},"NCT07715890","10002623","Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","NOT_YET_RECRUITING","2029-03-31","2026-07-21","2026-08-03","2026-08-06","National Heart, Lung, and Blood Institute (NHLBI)","NIH",null,"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.","Study Description:\n\nA controlled interventional study of effects of postprandial hypertriglyceridemia from three consecutive high-fat vitamin E-stripped meals on the dynamics of plasma vitamin E concentrations in subjects with baseline normo- and hyperlipidemia, to explore the concept of vitamin E sequestration by fats in plasma.\n\nObjectives:\n\nPrimary Objective: Compare effects of postprandial hypertriglyceridemia (PHTG) on plasma\u002Flipoprotein vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.\n\nSecondary Objectives: Compare effects of postprandial hypertriglyceridemia (PHTG) on other fat-soluble vitamins (gamma-tocopherol, phylloquinone \\[K1\\]; menaquinone \\[K2\\]; 25-OH vitamin D; retinol \\[A\\]) and related vitamers (beta-carotene, lycopene lutein\u002Fzeaxanthin) between subjects with baseline normo- and hyperlipidemia.\n\nTertiary\u002FExploratory Objectives:\n\n1. Compare effects of individual high-fat meals on the dynamics of vitamin E, gamma-tocopherol, phylloquinone \\[K1\\], menaquinone \\[K2\\], 25-OH vitamin D, retinol \\[A\\], and other carotenoids between subjects with baseline normo- and hyperlipidemia.\n2. Compare effects of postprandial hypertriglyceridemia (PHTG) and resultant vitamin E dynamics on: red blood cell (RBC) membrane deformability, fluidity, and oxygen exchange capacity (p50); RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid; fasting glucose and insulin; oxidized LDL, coenzyme Q10, and plasma adipokine profile between subjects with baseline normo- and hyperlipidemia;\n3. Explore effects of postprandial hypertriglyceridemia on small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.\n4. Explore the influence of genetic variance on the metabolism of vitamin E and other fat-soluble vitamins and related vitamers in subjects with baseline normo- and hyperlipidemia.\n\nEndpoints:\n\nPrimary Endpoint: AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23, by cohort.\n\nSecondary Endpoints: AUC of gamma-tocopherol, phylloquinone \\[K1\\], menaquinone \\[K2\\], 25-OH vitamin D and retinol \\[A\\] from hour 1 to hour 23, by cohort.\n\nTertiary\u002FExploratory Endpoints:\n\n1. Between the timepoints that reflect consuming 3 high-fat meals, AUC of vitamin E, gamma-tocopherol, phylloquinone \\[K1\\], menaquinone \\[K2\\], 25-OH vitamin D, retinol \\[A\\], and other carotenoids will be separately calculated for each participant.\n2. Over the course of inpatient visit, RBC membrane deformability\u002Ffluidity, p50, RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid, blood glucose, insulin, c-peptide, oxidized LDL, coenzyme Q10 and serum adipokine profiles in each subject.\n3. Over the course of inpatient visit, small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.\n4. Genetic variance (single nucleotide polymorphisms, SNPs)- dependent change in lipid-soluble vitamin dynamics over the course of inpatient visit in each subject.",[19],"Lipid Metabolism Disorders",[21,22,23,24,25,26,27,28,29,30],"Vitamin E","Vitamin K","Vitamin D","Vitamin C","Postprandial","Fat meal","Sequestration","Hypertriglyceridemia","Fat-Soluble Vitamins","gamma tocopherol","INTERVENTIONAL","BASIC_SCIENCE",[34],"NA",{"count":36,"type":37},48,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43},"DIETARY_SUPPLEMENT","High fat liquid shake","Three consecutive high-fat vitamin E-stripped meals",[44,45],"Healthy subjects","Subjects with hyperlipidemia",[47],{"measure":48,"description":49,"timeFrame":50},"AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.","Compare the effects of postprandial hypertriglyceridemia on plasma vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.","From hour 1 to hour 23",[52],{"measure":53,"description":54,"timeFrame":50},"AUC of gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A] from hour 1 to hour 23 by cohort.","Compare the effects of postprandial hypertriglyceridemia on other fat-soluble vitamins (gamma-tocopherol, phylloquinone \\[K1\\]; menaquinone \\[K2\\]; 25-OH vitamin D; retinol \\[A\\]) and related vitamers (beta-carotene, lycopene lutein\u002Fzeaxanthin) in subjects between baseline normo- and hyperlipidemia.","ALL","18 Years","65 Years",false,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"* 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",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":84},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Robert Shamburek, M.D.","CONTACT","301-496-3460","bobs@mail.nih.gov",{"name":80,"role":76,"phone":81,"phoneExt":82,"email":83},"NIH Clinical Center Office of Patient Recruitment (OPR)","(800) 411-1222","TTY dial 711","ccopr@nih.gov",{"lat":85,"lon":86},38.98067,-77.10026,[88,92],{"name":89,"role":76,"phone":90,"email":91},"Katherine C Roskom, R.N.","(301) 451-7094","katherine.roskom@nih.gov",{"name":93,"role":76,"phone":94,"email":78},"Robert D Shamburek, M.D.","(301) 496-3460",[96],{"name":93,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",[99],{"pmid":100,"type":101,"citation":102},"31495886","BACKGROUND","Traber MG, Leonard SW, Ebenuwa I, Violet PC, Wang Y, Niyyati M, Padayatty S, Tu H, Courville A, Bernstein S, Choi J, Shamburek R, Smith S, Head B, Bobe G, Ramakrishnan R, Levine M. Vitamin E absorption and kinetics in healthy women, as modulated by food and by fat, studied using 2 deuterium-labeled alpha-tocopherols in a 3-phase crossover design. Am J Clin Nutr. 2019 Nov 1;110(5):1148-1167. doi: 10.1093\u002Fajcn\u002Fnqz172.",[104],{"label":105,"url":106},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?B_002623-H.html",{"nct_id":4,"conditions":108,"biomarkers":113},[109,110,28,111,112],"Diabetes Mellitus","Healthy Volunteers","Lipid Metabolism Disorder","Obesity",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study, meaning participants will receive a specific intervention (high-fat meals). It plans to enroll 48 participants.","completed","Understanding Vitamin E and High Blood Fat Levels","This study is looking at how high-fat meals affect vitamin E levels in your blood. Researchers want to understand if high levels of fat in the blood (hyperlipidemia) might prevent important nutrients like vitamin E from getting where they need to go in the body. You would receive three high-fat vitamin E-stripped meals as part of the study. The main goal is to measure the amount of vitamin E in your blood over 23 hours after these meals. This study is for people aged 18 to 65 who have lipid metabolism disorders (high blood fat levels), and healthy volunteers are also needed. The study is currently recruiting 48 participants.","Your vitamin E levels will be measured from hour 1 to hour 23 after the intervention.",109,"You will have 3 or 4 clinic visits over 3 months, with the last visit requiring a 2-night stay in the clinic. You will undergo a physical exam and blood tests, and must stop taking dietary supplements before the study.","Not stated in the trial record.",[],"v2"]