ClinicalTrials.gg
Sign In
Not yet recruitingNCT07715890Updated Nov 10, 2026

Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

An interventional study of High fat liquid shake in Lipid Metabolism Disorders, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Basic science

Updated Nov 10, 2026Start date movedEligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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:

  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 (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;

  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, 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.
  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.
02

Conditions studied

  • Lipid Metabolism Disorders

Keywords

  • Vitamin E
  • Vitamin K
  • Vitamin D
  • Vitamin C
  • Postprandial
  • Fat meal
  • Sequestration
  • Hypertriglyceridemia
  • Fat-Soluble Vitamins
  • gamma tocopherol
03

In context

Lipid Metabolism Disorders

177 studies on the registry are indexed under Lipid Metabolism Disorders; 36 are open to participants now.

This study's planned enrollment of 48 is below the median of 60 across 129 interventional studies indexed under Lipid Metabolism Disorders.

Browse Lipid Metabolism Disorders studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.

Browse National Heart, Lung, and Blood Institute (NHLBI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cohort 1

  • Males and females aged 18 to 65 years.
  • 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.

  • At screening, laboratory values meet all of the following:

    • \< 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 , 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%.

Exclusion criteria

EXCLUSION CRITERIA:

  • 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.
  • Subjects with lactose intolerance who are unwilling to take lactase.
  • Subjects with type 1 diabetes.
  • Subjects with \<11 g/dL or hematocrit \<33%.
  • Subjects with 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 for more than 1 week (not including topical glucocorticoids) within past 3 months.
  • Subjects with .
  • 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Healthy subjects

    Three consecutive high-fat vitamin E-stripped meals

    Dietary Supplement: High fat liquid shake

  • Experimental
    Subjects with hyperlipidemia

    Three consecutive high-fat vitamin E-stripped meals

    Dietary Supplement: High fat liquid shake

Interventions

  • Dietary supplementHigh fat liquid shake

    Three consecutive high-fat vitamin E-stripped meals

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: From hour 1 to hour 23

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • Robert Shamburek, M.D. · Contactbobs@mail.nih.gov · 301-496-3460
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · (800) 411-1222
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.@@@@@@

Supporting information: Study protocol, Informed consent form

Time frame: 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.

Access criteria: 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.

09

Updates

32 registry updates since Sep 25, 2026
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Eligibility
6 inclusion criteria edited, 11 added, 4 removed; 13 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedMales and females between the ages ofaged 18 to 65 years.
  • EditedBMI 18.5 - 26.9 kg/m\^2 .
  • RemovedSubject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
  • RemovedNormotensive, not on medications for hypertension
  • AddedAble to understand the study procedures and provide written consent, and willing to comply with all scheduled follow-up visits and assessments.
  • AddedNormotensive and not on antihypertensive medications, blood pressure 90-129/60-84.
  • EditedNot on glucose-lowering or lipid-lowinglowering medications.
  • RemovedScreening labs with baseline HbA1c <5.7%, baseline fasting triglyceride < 150 mg/dL and LDL <100 mg/dL
  • AddedAt screening, laboratory values meet all of the following:
  • AddedHbA1c < 5.7%,
  • AddedFasting triglycerides < 150 mg/dL
  • AddedLDL < 100 mg/dL
  • EditedMales and females between the ages ofaged 18 to 65 years.
  • ChangedBefore BMI >26 kg/m\^2 and <36 kg/m\^2Now BMI > 26.0 to < 36.0 kg/m2.
  • EditedSubject understandsAble to understand the protocolstudy procedures and providesprovide written, informed consent in addition to a willingness, and willing to comply with specifiedall scheduled follow-up instructionsvisits and evaluationsassessments.
  • RemovedScreening 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.
  • AddedAt screening, laboratory values meet all of the following:
  • AddedHbA1c <= 7.5%
  • AddedFasting triglycerides < 500 mg/dL
  • AddedLDL < 190 mg/dL
  • AddedWilling to discontinue oral glucose-lowering medications (metformin) and oral lipidlowering medications for 4 to 10 weeks prior to the inpatient visit, if applicable.
Exclusion criteria
  • EditedFor women: pregnancyWomen who are pregnant or currently breastfeeding.
  • EditedSubjects <younger than 18-year- years 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.
  • EditedSubjects >older than 65-year-old 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, we exclude these individuals are excluded.
  • EditedHeavy alcohol useruse within past 12 months (males with: >2 drinks per day or >14 drinks per week; female withfemales: >1 drinksdrink per day or >7 drinks per week).
  • EditedCurrent smoker, or former smoker who quit smoking <less than 15 years ago.
  • EditedSubjects 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.
  • EditedSubjects with lactose intolerance who are unwilling to take lactase.
  • EditedSubjects with clinically significant abnormal liver function test results.
  • EditedSubjects with fat malabsorption, including: a history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, andor pathologic mutations impacting lipoprotein metabolism.
  • EditedSubjects on glucocorticoids >for more than 1 week (not including topical glucocorticoids) within past 3 months.
  • EditedAnticipatedSubjects with anticipated surgery during the study period.
  • EditedSubjects who are unwilling to stop medications, vitamins, and/or dietary supplements that investigators have requested to be held.
  • EditedAny other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for athe participant or staff member.
Sep 25, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
    + 1 other change: verification date
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
    + 1 other change: verification date
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
    + 1 other change: verification date
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
    + 1 other change: description
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026
    Eligibility 6 inclusion criteria edited, 11 added, 4 removed; 13 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedMales and females between the ages ofaged 18 to 65 years.
    • EditedBMI 18.5 - 26.9 kg/m\^2 .
    • RemovedSubject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
    • RemovedNormotensive, not on medications for hypertension
    • AddedAble to understand the study procedures and provide written consent, and willing to comply with all scheduled follow-up visits and assessments.
    • AddedNormotensive and not on antihypertensive medications, blood pressure 90-129/60-84.
    • EditedNot on glucose-lowering or lipid-lowinglowering medications.
    • RemovedScreening labs with baseline HbA1c <5.7%, baseline fasting triglyceride < 150 mg/dL and LDL <100 mg/dL
    • AddedAt screening, laboratory values meet all of the following:
    • AddedHbA1c < 5.7%,
    • AddedFasting triglycerides < 150 mg/dL
    • AddedLDL < 100 mg/dL
    • EditedMales and females between the ages ofaged 18 to 65 years.
    • ChangedBefore BMI >26 kg/m\^2 and <36 kg/m\^2Now BMI > 26.0 to < 36.0 kg/m2.
    • EditedSubject understandsAble to understand the protocolstudy procedures and providesprovide written, informed consent in addition to a willingness, and willing to comply with specifiedall scheduled follow-up instructionsvisits and evaluationsassessments.
    • RemovedScreening 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.
    • AddedAt screening, laboratory values meet all of the following:
    • AddedHbA1c <= 7.5%
    • AddedFasting triglycerides < 500 mg/dL
    • AddedLDL < 190 mg/dL
    • AddedWilling to discontinue oral glucose-lowering medications (metformin) and oral lipidlowering medications for 4 to 10 weeks prior to the inpatient visit, if applicable.
    Exclusion criteria
    • EditedFor women: pregnancyWomen who are pregnant or currently breastfeeding.
    • EditedSubjects <younger than 18-year- years 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.
    • EditedSubjects >older than 65-year-old 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, we exclude these individuals are excluded.
    • EditedHeavy alcohol useruse within past 12 months (males with: >2 drinks per day or >14 drinks per week; female withfemales: >1 drinksdrink per day or >7 drinks per week).
    • EditedCurrent smoker, or former smoker who quit smoking <less than 15 years ago.
    • EditedSubjects 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.
    • EditedSubjects with lactose intolerance who are unwilling to take lactase.
    • EditedSubjects with clinically significant abnormal liver function test results.
    • EditedSubjects with fat malabsorption, including: a history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, andor pathologic mutations impacting lipoprotein metabolism.
    • EditedSubjects on glucocorticoids >for more than 1 week (not including topical glucocorticoids) within past 3 months.
    • EditedAnticipatedSubjects with anticipated surgery during the study period.
    • EditedSubjects who are unwilling to stop medications, vitamins, and/or dietary supplements that investigators have requested to be held.
    • EditedAny other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for athe participant or staff member.
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07715890
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Katherine C Roskom, R.N.
Contact
katherine.roskom@nih.gov
(301) 451-7094
Robert D Shamburek, M.D.
Contact
bobs@mail.nih.gov
(301) 496-3460
Robert D Shamburek, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lipid Metabolism Disorders →

Other studies from this sponsor

National Heart, Lung, and Blood Institute (NHLBI) →

Start the discussion