Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07715890
Status
Not Yet Recruiting

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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

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.

Key Dates

First listed
Jul 21, 2026
Start date
Sep 8, 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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Robert Shamburek, M.D.
[email protected]
301-496-3460
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
(800) 411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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