N/A
Completed N=100
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
Source: ClinicalTrials.gov NCT01048502 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). — 0.95; 1.26; 1.14; 1.12 pg/mL
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). |
0.95; 1.26; 1.14; 1.12; 1.25; 0.99 | — |
| SECONDARY Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. |
1.2; 1.5; 1.1; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Men and non-pregnant/lactating women between the ages of 18 and 45.
- Body Mass Index (BMI) ≥18 and ≤30
- Participants who are able to give written informed consent and willing to comply with all study-related procedures.
Exclusion Criteria
- 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 1.5x upper limit of normal (ULN); bilirubin > 2x ULN) at Screening Visit
- Men who are unwilling to limit alcohol consumption to 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 (eicosapentaenoic acid (EPA) + docosahexaenoic acid (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 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) criteria.
- Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
Data sourced from ClinicalTrials.gov (NCT01048502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.