Cardiovascular Disease Clinical Trial
Official title:
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia: The FFAME Study
The purpose of this study is to better understand the anti-inflammatory benefits of two
prescription medicines that are currently used to help people with cholesterol problems.
Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help
control cholesterol and reduce inflammation (the body's response to injury or sickness).
Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will
be looking at how Lovaza® works to help reduce inflammation in healthy volunteers.
Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription
medicine that many doctors give to people with high triglyceride (fat in the blood) levels.
In this study, we will be looking at how Tricor® works to help reduce inflammation in
healthy volunteers.
Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living)
that can cause many of the effects similar to bacterial infections in humans. However, it
can be administered in very small amounts to produce a mild immune response much the same as
a 'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of
fever, chills, headache, nausea and vomiting and generalized aches and pains will occur
which lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes
temporary changes in cholesterol, triglycerides and blood sugar. Different people respond
differently to LPS. We are using LPS in this study to bring on a temporary inflammatory
response in the body and to compare the responses of people who receive Lovaza® or Tricor®
to the responses of people who receive a placebo (pill that does not contain medicine).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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