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Not Yet Recruiting NCT07715890

Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

Conditions: Lipid Metabolism Disorders

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Location: National Institutes of Health Clinical Center Bethesda Maryland

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.

Eligibility Criteria

* INCLUSION CRITERIA: Cohort 1 * Males and females aged 18 to 65 years. * BMI 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: * HbA1c \< 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 informed consent, and willing to comply with all scheduled follow-up visits and assessments. * At screening, laboratory values meet all of the following: * HbA1c \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 hemoglobin \

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Source: ClinicalTrials.gov (NCT07715890). StuddyBuddy aggregates publicly available trial information.