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
Among 62 studies in Lipid Metabolism Disorders with a site in United States — 10 open to participants now, 15 under way, 1 of them phase 3. Lipid Metabolism Disorders · United States.
Among the 62 studies in Lipid Metabolism Disorders with a site in United States, this one is the 28th largest by planned enrollment of the 51 interventional ones that give a count, is one of 2 that started in 2026, is one of 16 with no phase, reaches primary completion later than 14 of the 14 other live ones, and was the 62nd registered.
177 studies on the registry are indexed under Lipid Metabolism Disorders; 36 are open to participants now.
Browse Lipid Metabolism Disorders studies →10 of the 62 studies in Lipid Metabolism Disorders with a site in United States are open now. Recruiting first, the newest first:
Arrowhead Pharmaceuticals · Sites in United States, Denmark, Poland
The Miriam Hospital · Sites in United States
Wake Forest University Health Sciences · Sites in United States
The Miriam Hospital · Sites in United States
CRISPR Therapeutics AG · Sites in United States, Australia, New Zealand and 1 more country
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Lipid Metabolism Disorders studies recruiting now, 5 (20%) set no upper age limit and 18 (72%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
62 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 19 · Phase 3 5 · Phase 4 4
First in 2006; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 60 across 129 interventional studies indexed under Lipid Metabolism Disorders.
Median enrollment 51 across the 51 interventional studies, 63 across the 10 observational. Of the 44 that completed or were terminated, 21 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 62 have an industry lead sponsor. The 10 most frequent:
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.
National Heart, Lung, and Blood Institute (NHLBI) has 2 studies filed under Lipid Metabolism Disorders — fewer than ten, so there is no comparison to draw.
6 of the studies in Lipid Metabolism Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05693701University of Texas Southwestern Medical CenterMulticomponent Intervention Study- Blood Donors With High Cholesterol | 2027-04-30 |
| NCT07491172CRISPR Therapeutics AGA Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias | 2027-06 |
| NCT05539716University of MiamiMetabolism and Sleep Apnea Treatment | 2027-06-01 |
| NCT05611307Indiana UniversityLate Subclinical Cardiovascular Disease in Testicular Cancer Survivors | 2027-07 |
| NCT06494488The Miriam HospitalDifferential Thrombogenesis by EPA and DHA Mediated by HDL | 2027-08-01 |
Among the 62 studies in Lipid Metabolism Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 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;
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:
The criteria were revised on the registry on Sep 25, 2026. See what changed
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.
Cohort 1
At screening, laboratory values meet all of the following:
LDL \< 100 mg/dL
7. Liver fat \< 2%.
Cohort 2
At screening, laboratory values meet all of the following:
EXCLUSION CRITERIA:
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.
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.
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.
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.
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).
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three consecutive high-fat vitamin E-stripped meals
Dietary Supplement: High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals
Dietary Supplement: High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals
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
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
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.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 39 non-industry interventional studies with no phase under Lipid Metabolism Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 71. This study's planned 24 months is above that.
Counting every sponsor, half of 46 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI) →