Lipid Metabolism DisordersNCT07715890
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
A study testing High fat liquid shake in people with Lipid Metabolism Disorders, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Obesity 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- High fat liquid shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 31 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1
- Males and females aged 18 to 65 years.
- BMI 18.5 26.9 kg/m^2 .
- Able to understand the study procedures and provide written consent, and willing to comply with all scheduled follow-up visits and assessments.
- Normotensive and not on antihypertensive medications, blood pressure 90-129/60-84.
- Not on glucose-lowering or lipid-lowering medications.
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- At screening, laboratory values meet all of the following:
- HbA1c < 5.7%,
- Fasting triglycerides < 150 mg/dL
- LDL < 100 mg/dL
- 7. Liver fat < 2%.
- Cohort 2
- Males and females aged 18 to 65 years.
- BMI > 26.0 to < 36.0 kg/m2.
- Able to understand the study procedures and provide written informed consent, and willing to comply with all scheduled follow-up visits and assessments.
- At screening, laboratory values meet all of the following:
- HbA1c <= 7.5%
- Fasting triglycerides < 500 mg/dL
- LDL < 190 mg/dL
- Willing to discontinue oral glucose-lowering medications (metformin) and oral lipidlowering medications for 4 to 10 weeks prior to the inpatient visit, if applicable.
- Liver fat < 2%.
Who cannot join
- Women who are pregnant or currently breastfeeding.
- Subjects younger than 18 years old. This age group has a broad spectrum of hormonal profiles due to development and puberty, which significantly increases the heterogenicity of study subjects.
- Subjects older than 65 years. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and the stress from serial blood draws, these individuals are excluded.
- Heavy alcohol use within past 12 months (males: >2 drinks per day or >14 drinks per week; females: >1 drink per day or >7 drinks per week).
- Current smoker, or former smoker who quit smoking less than 15 years ago.
- Subjects with weight changes greater than 20% of baseline body weight (self-reported or documented within past 12 months) over the past 3 months at outpatient visit 1, or change from outpatient visit 1 during screening.
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- Subjects with lactose intolerance who are unwilling to take lactase.
- Subjects with type 1 diabetes.
- Subjects with hemoglobin <11 g/dL or hematocrit <33%.
- Subjects with clinically significant abnormal liver function test results.
- Subjects with liver fat >= 2% on abdominal MRI.
- Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases.
- Subjects with fat malabsorption, including a history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, or pathologic mutations impacting lipoprotein metabolism.
- Subjects on glucocorticoids for more than 1 week (not including topical glucocorticoids) within past 3 months.
- Subjects with HIV.
- Subjects with uncontrolled psychiatric and/or behavioral disorders.
- Subjects taking diabetes medications other than metformin.
- Subjects with anticipated surgery during the study period.
- Subjects with severe medication-resistant claustrophobia.
- Subjects who are unwilling to stop medications, vitamins, and/or dietary supplements that investigators have requested to be held.
- Subjects participating in any other clinical study without informing investigators.
- Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for the participant or staff member.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Robert Shamburek, M.D., 301-496-3460, bobs@mail.nih.gov
NIH Clinical Center Office of Patient Recruitment (OPR), (800) 411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Background:
Obesity 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.
Read more
Objective:
To learn how high-fat meals affect levels of vitamin E in the blood.
Eligibility:
People aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.
Design:
Participants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.
Participants will be screened. They will have a physical exam and blood tests.
After this visit, all participants must stop taking any dietary supplements.
Those 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.
The next visit will include 2 imaging scans:
Magnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.
Dual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.
On day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.
On day 2, they will drink high-fat shakes at 9am, 1pm, and 5pm. They will have blood draws every 30 minutes for the first hour, every hour the next 16 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.
On day 3, they will go home.
Read the detailed description
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:
- 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.
- Compare effects of postprandial hypertriglyceridemia (PHTG) and resultant vitamin E dynamics on: red blood cell (RBC) membrane deformability, fluidity, and oxygen exchange capacity (pO2, p50); RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid; fasting glucose and insulin; oxidized LDL, coenzyme Q10, and plasma cytokine/adipokine profile between subjects with baseline normo- and hyperlipidemia;
- Explore effects of postprandial hypertriglyceridemia on small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
- 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:
- 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.
- Over the course of inpatient visit, RBC membrane deformability/fluidity, pO2, p50, RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid, blood glucose, insulin, c-peptide, oxidized LDL, coenzyme Q10 and serum cytokine/adipokine profiles in each subject.
- Over the course of inpatient visit, small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
- Genetic variance (single nucleotide polymorphisms, SNPs)- dependent change in lipid-soluble vitamin dynamics over the course of inpatient visit in each subject.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- High fat liquid shake
- Keywords
- Vitamin E, Vitamin K, Vitamin D, Vitamin C, Postprandial, Fat meal, Sequestration, Hypertriglyceridemia, Fat-Soluble Vitamins, gamma tocopherol
- Medical subject headings
- Lipid Metabolism Disorders, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat liquid shakeDietary supplement
Three consecutive high-fat vitamin E-stripped meals
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | Three consecutive high-fat vitamin E-stripped meals Receives: Dietary Supplement: High fat liquid shake |
| Subjects with hyperlipidemia | Experimental | Three consecutive high-fat vitamin E-stripped meals Receives: Dietary Supplement: High fat liquid shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hour 1 to hour 23
Secondary outcomes (1)
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/zeaxanthin) in subjects between baseline normo- and hyperlipidemia.
Measured: From hour 1 to hour 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert D Shamburek, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715890
- Sponsor's protocol ID
- 10002623
- Other IDs
- 002623-H
- Status last verified
- 14 Oct 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.@@@@@@
Publications
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/ajcn/nqz172.
PubMed 31495886