High Fat Liquid Shake for Lipid Disorder
What You Need to Know Before You Apply
What is the purpose of 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 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 Is on the Research Team?
Robert D Shamburek, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65, both healthy and those with high blood fat levels. Participants must not have significant liver fat, major health issues, or recent large weight changes. They can't be pregnant, breastfeeding, current smokers, or unable to stop certain medications and supplements as required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment Adjustment
Participants stop taking dietary supplements and drugs to lower blood sugar and blood fats
Treatment
Participants consume three consecutive high-fat vitamin E-stripped meals and undergo various tests including MRI and DEXA scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests how drinking high-fat shakes affects vitamin E levels in the blood. Participants will attend several clinic visits over three months and undergo scans and frequent blood draws after consuming the shakes to track nutrient changes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Three consecutive high-fat vitamin E-stripped meals
Three consecutive high-fat vitamin E-stripped meals
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
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