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Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia (FFAME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01048502
First received: January 11, 2010
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention
Cardiovascular Disease
Drug: Fenofibrate tablets
Drug: Placebo
Drug: Lovaza

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia: The FFAME Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tricor (145 mg/day)
Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Drug: Fenofibrate tablets
One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
Placebo Comparator: Placebo
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Drug: Placebo
Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
Experimental: Lovaza (900 mg/day)
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Drug: Lovaza
900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
Experimental: Lovaza (3,600 mg/day)
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Drug: Lovaza
900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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 <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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048502

Locations
United States, Pennsylvania
Clinical and Translational Research Center (CTRC); Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
GlaxoSmithKline
Investigators
Principal Investigator: Muredach P Reilly, MB, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: Muredach P. Reilly, MB, MSCE - Assistant Professor of Medicine and Pharmacology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01048502     History of Changes
Other Study ID Numbers: 810598, P50HL083799
Study First Received: January 11, 2010
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
healthy volunteer

Additional relevant MeSH terms:
Cardiovascular Diseases
Endotoxemia
Bacteremia
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Toxemia
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014