Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia (NCT07715890) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
United States48 participantsStarted 2026-08-18
Plain-language 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 8 am, noon, and 4 pm. They will have blood draws every hour for 17 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females between the ages of 18 to 65
. BMI 18.5 - 26.9 kg/m\^2
. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
. Normotensive, not on medications for hypertension
. Not on glucose-lowering or lipid-lowing medications
. Screening labs with baseline HbA1c \<5.7%, baseline fasting triglyceride \< 150 mg/dL and LDL \<100 mg/dL
. Liver fat \<2%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.
Timeframe: From hour 1 to hour 23
Trial details
NCT IDNCT07715890
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
. 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.
. 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.
. 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)
. Current smoker, or former smoker who quit smoking \<15 years ago
. Subjects with weight changes greater than 20% baseline body weight over the past 3 months
. Subjects with lactose intolerance unwilling to take lactase