Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
This trial is active, not recruiting.
|Treatments||fenofibrate tablets, placebo, lovaza|
|Sponsor||University of Pennsylvania|
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||January 2010|
|End date||May 2011|
|Trial size||100 participants|
|Trial identifier||NCT01048502, 810598, P50HL083799|
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).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
|Primary purpose||basic science|
Both omega-3 fatty acid and fenofibrate supplementation will attenuate cytokine production (plasma levels of TNFα) during an in vivo inflammatory challenge (LPS).
time frame: 6 to 8 weeks
Both omega-3 fatty acid and fenofibrate supplementation will attenuate downstream inflammatory, insulin resistance and lipoprotein changes induced by endotoxemia; a) e.g., IL-6, MCP-1, CRP, b) Increases in HOMA-IR c) Change in HDL parameter
time frame: 6 to 8 weeks
Male or female participants from 18 years up to 45 years old.
- Men and non-pregnant/lactating women between the ages of 18 and 45.
- BMI ≥18 and ≤30
- Participants who are able to give written informed consent and willing to comply with all study-related procedures.
- Known clinically manifest atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus
- Fasting glucose >126mg/dL at screening
- History of a non-skin malignancy within the previous 5 years
- Renal insufficiency as defined by creatinine outside of lab defined normal range or eGFR <60 ml/Kg/min at Screening Visit
- History of liver disease or abnormal LFTs (AST, ALT, Alk. Phos., GGT > 1.5x ULN; bilirubin > 2x ULN) at Screening Visit
- Men who are unwilling to limit alcohol consumption to < 14 alcoholic drinks per week or < 4 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage levels) while participating in the study
- Women who are unwilling to limit alcohol consumption to < 7 alcoholic drinks per week or < 3 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage levels) while participating in the study
- Total white blood cell count less than or equal to 3.0 THO/uL
- Hemoglobin less than 11.0 g/dL
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection
- Self-reported history of HIV positive
- First degree family history of premature cardiovascular disease event (father or brother if diagnosed at before 55 years of age; mother or sister if diagnosed before 65 years of age)
- Patients who have undergone any organ transplant
- Individuals who currently use tobacco products or have done so in the previous 30 days
- Treatment with aspirin, NSAIDs, COX-2 inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit
- Treatment with statins, fibrates or niacin 4 weeks prior to the Screening Visit.
- Current daily use of Vitamin C > 1000 mg, Beta carotene > 1000 IU, vitamin A > 5000 IU, vitamin E > 400 IU, and selenium > 200 mcg
- Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements and/or fortified food, or have their usual intake of high omega-3 fish (tuna and other non-fried fish) be > 3 to 4 servings per month as assessed by a simple screening questionnaire
- Positive urine pregnancy test result.
- Participation in another clinical trial within the previous 6 weeks prior to the Screening Visit.
- Poorly controlled blood pressure (BP > 160/110) or on any anti-hypertensive medications.
- A diagnosis of metabolic syndrome using updated 2004 NCEP ATPIII criteria.
- Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
|Official title||Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia: The FFAME Study|
|Principal investigator||Muredach P Reilly, MB, MSCE|
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