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Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

18. juli 2026 opdateret af: National Heart, Lung, and Blood Institute (NHLBI)

Study Description:

A 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.

Objectives:

Primary Objective: Compare effects of postprandial hypertriglyceridemia (PHTG) on plasma/lipoprotein vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.

Secondary 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/zeaxanthin) between subjects with baseline normo- and hyperlipidemia.

Tertiary/Exploratory Objectives:

  1. 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.
  2. 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;
  3. Explore effects of postprandial hypertriglyceridemia on small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. 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.

Endpoints:

Primary Endpoint: AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23, by cohort.

Secondary Endpoints: AUC of gamma-tocopherol, phylloquinone [K1], menaquinone [K2], 25-OH vitamin D and retinol [A] from hour 1 to hour 23, by cohort.

Tertiary/Exploratory Endpoints:

  1. 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.
  2. Over the course of inpatient visit, RBC membrane deformability/fluidity, 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.
  3. Over the course of inpatient visit, small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. Genetic variance (single nucleotide polymorphisms, SNPs)- dependent change in lipid-soluble vitamin dynamics over the course of inpatient visit in each subject.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Description:

A 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.

Objectives:

Primary Objective: Compare effects of postprandial hypertriglyceridemia (PHTG) on plasma/lipoprotein vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.

Secondary 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/zeaxanthin) between subjects with baseline normo- and hyperlipidemia.

Tertiary/Exploratory Objectives:

  1. 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.
  2. 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;
  3. Explore effects of postprandial hypertriglyceridemia on small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. 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.

Endpoints:

Primary Endpoint: AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23, by cohort.

Secondary Endpoints: AUC of gamma-tocopherol, phylloquinone [K1], menaquinone [K2], 25-OH vitamin D and retinol [A] from hour 1 to hour 23, by cohort.

Tertiary/Exploratory Endpoints:

  1. 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.
  2. Over the course of inpatient visit, RBC membrane deformability/fluidity, 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.
  3. Over the course of inpatient visit, small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. Genetic variance (single nucleotide polymorphisms, SNPs)- dependent change in lipid-soluble vitamin dynamics over the course of inpatient visit in each subject.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Robert D Shamburek, M.D.
  • Telefonnummer: (301) 496-3460
  • E-mail: bobs@mail.nih.gov

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center
        • Kontakt:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Telefonnummer: TTY dial 711 (800) 411-1222
          • E-mail: ccopr@nih.gov
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

  • INCLUSION CRITERIA

Cohort 1

  1. Males and females between the ages of 18 to 65
  2. BMI 18.5 - 26.9 kg/m^2
  3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
  4. Normotensive, not on medications for hypertension
  5. Not on glucose-lowering or lipid-lowing medications
  6. Screening labs with baseline HbA1c <5.7%, baseline fasting triglyceride < 150 mg/dL and LDL <100 mg/dL
  7. Liver fat <2%

Cohort 2

  1. Males and females between the ages of 18 to 65
  2. BMI >26 kg/m^2 and <36 kg/m^2
  3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.
  4. Screening labs with baseline HbA1c <= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride < 500 mg/dL and LDL <190 mg/dL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.
  5. Liver fat <2%

EXCLUSION CRITERIA

  1. For women: pregnancy or currently breastfeeding
  2. Subjects <18-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.
  3. 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.
  4. 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)
  5. Current smoker, or former smoker who quit smoking <15 years ago
  6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months
  7. Subjects with lactose intolerance unwilling to take lactase
  8. Subjects with type 1 diabetes
  9. Subjects with hemoglobin <11 g/dL or hematocrit <33%
  10. Subjects with abnormal liver function test results
  11. Subjects with liver fat >= 2% on abdominal MRI
  12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases
  13. 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
  14. Subjects on glucocorticoids >1 week (not including topical glucocorticoids)
  15. Subjects with HIV
  16. Subjects with uncontrolled psychiatric and/or behavioral disorders
  17. Subjects taking diabetes medications other than metformin
  18. Anticipated surgery during the study period
  19. Subjects with severe medication-resistant claustrophobia
  20. Subjects who are unwilling to stop medications, vitamins and/or dietary supplements that investigators have requested to be held
  21. Subjects participating in any other clinical study without informing investigators
  22. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a participant or staff member

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Healthy subjects
Three consecutive high-fat vitamin E-stripped meals
Kosttilskud: High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals
Eksperimentel: Subjects with hyperlipidemia
Three consecutive high-fat vitamin E-stripped meals
Kosttilskud: High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.
Tidsramme: From hour 1 to hour 23
Compare the effects of postprandial hypertriglyceridemia on plasma vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.
From hour 1 to hour 23

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUC of gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A] from hour 1 to hour 23 by cohort.
Tidsramme: From hour 1 to hour 23
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/zeaxanthin) in subjects between baseline normo- and hyperlipidemia.
From hour 1 to hour 23

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: Robert D Shamburek, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. november 2028

Studieafslutning (Anslået)

31. marts 2029

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

15. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10002623
  • 002623-H

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying results reported in publications may be shared. Depending on the sensitivity of the dataset and risk of re-identification, data may be made available through either an open-access repository or a controlled-access repository, consistent with informed consent, institutional review, and applicable policies.@@@@@@

IPD-delingstidsramme

Beginning following de-identification and publication of the primary results, or other prespecified time point, and continuing for as long as the repository or access mechanism remains available.

IPD-delingsadgangskriterier

Access to de-identified individual participant data will be determined based on the sensitivity of the data and disclosure risk. Data appropriate for broad sharing may be deposited in an open-access repository. Data requiring additional protections may be made available through a controlled-access mechanism subject to review and any applicable agreements.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lipidmetabolismeforstyrrelser

Kliniske forsøg med High fat liquid shake

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Colombia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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