About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged 18 to 65 years.
BMI 18.5 26.9 kg/m² .
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
High fat liquid shake
Dietary supplementThree consecutive high-fat vitamin E-stripped meals
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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