Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

Conditions

• Lipid Metabolism Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• High fat liquid shake — DIETARY_SUPPLEMENT
  Three consecutive high-fat vitamin E-stripped meals

Study Details

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.

Key Dates

First listed

Jul 21, 2026

Start date

Aug 1, 2026

Status verified

Jul 2026

Primary completion

Nov 30, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Healthy subjects
  Three consecutive high-fat vitamin E-stripped meals
• Experimental: Subjects with hyperlipidemia
  Three consecutive high-fat vitamin E-stripped meals

Primary Outcome Measure

AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort. [ Time Frame: From hour 1 to hour 23 ]

Central Contacts

• Katherine C Roskom, R.N.
  (301) 451-7094
  [email protected]
• Robert D Shamburek, M.D.
  (301) 496-3460
  [email protected]

Locations (1)

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