Cardiovascular DiseaseFFAMENCT01048502
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
A study testing Fenofibrate (Tricor) tablets and Lovaza in people with Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fenofibrate (Tricor) tablets and Lovaza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 Liver Function Tests (LFTs) (aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma-glutamyl transpeptidase (GGT) > 1.5x upper limit of normal (ULN); bilirubin > 2x ULN) at Screening Visit
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- Men who are unwilling to limit alcohol consumption to < 14 alcoholic drinks per week or < 4 alcoholic drinks per occasion (American Medical Association/National Institute on Alcohol Abuse and Alcoholism (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, Nonsteroidal Anti-inflammatory Drugs (NSAIDs), cyclooxygenase-2 (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 (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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center (CTRC); Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read more
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).
- Conditions
- Cardiovascular Disease
- Being tested
- Fenofibrate (Tricor) tablets, Placebo, Lovaza
- Keywords
- healthy volunteer
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate (Tricor) tabletsDrug
One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
PlaceboDrug
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
LovazaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate (Tricor) (145 mg/day) | Experimental | Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks. Receives: Drug: Fenofibrate (Tricor) tablets |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Lovaza (900 mg/day) | Experimental | 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. Receives: Drug: Lovaza |
| Lovaza (3,600 mg/day) | Experimental | Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks. Receives: Drug: Lovaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).
Measured: randomization and 8 weeks post
Secondary outcomes (1)
Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.
Measured: baseline and 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muredach P Reilly, MB, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048502
- Sponsor's protocol ID
- 810598
- Other IDs
- P50HL083799
- Acronym
- FFAME
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2010
- Last updated
- 19 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ferguson JF, Xue C, Hu Y, Li M, Reilly MP. Adipose tissue RNASeq reveals novel gene-nutrient interactions following n-3 PUFA supplementation and evoked inflammation in humans. J Nutr Biochem. 2016 Apr;30:126-32. doi: 10.1016/j.jnutbio.2015.12.010. Epub 2016 Jan 11.
PubMed 27012629Mulvey CK, Ferguson JF, Tabita-Martinez J, Kong S, Shah RY, Patel PN, Master SR, Usman MH, Propert KJ, Shah R, Mehta NN, Reilly MP. Peroxisome Proliferator-Activated Receptor-alpha Agonism With Fenofibrate Does Not Suppress Inflammatory Responses to Evoked Endotoxemia. J Am Heart Assoc. 2012 Aug;1(4):e002923. doi: 10.1161/JAHA.112.002923. Epub 2012 Aug 24.
PubMed 23130172
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia: The FFAME Study
- ClinicalTrials.gov ID
- NCT01048502
- Acronym / sponsor ID
- FFAME / 810598
- Conditions
- Cardiovascular Disease
- Keywords
- healthy volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 19 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate (Tricor) (145 mg/day) | Experimental | Drug: Fenofibrate (Tricor) tabletsParticipants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Lovaza (900 mg/day) | Experimental | Drug: LovazaParticipants 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. |
| Lovaza (3,600 mg/day) | Experimental | Drug: LovazaParticipants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate (Tricor) tabletsOne 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks | Drug | Fenofibrate (Tricor) (145 mg/day) |
| PlaceboTwo 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 | Drug | Placebo |
| Lovaza900 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. | Drug | Lovaza (3,600 mg/day), Lovaza (900 mg/day) |
Primary outcome
The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).
Time frame: randomization and 8 weeks post
1 secondary outcome
Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.
Time frame: baseline and 6-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27012629Ferguson JF, Xue C, Hu Y, Li M, Reilly MP. Adipose tissue RNASeq reveals novel gene-nutrient interactions following n-3 PUFA supplementation and evoked inflammation in humans. J Nutr Biochem. 2016 Apr;30:126-32. doi: 10.1016/j.jnutbio.2015.12.010. Epub 2016 Jan 11.
- Derived from this study: PubMed 23130172Mulvey CK, Ferguson JF, Tabita-Martinez J, Kong S, Shah RY, Patel PN, Master SR, Usman MH, Propert KJ, Shah R, Mehta NN, Reilly MP. Peroxisome Proliferator-Activated Receptor-alpha Agonism With Fenofibrate Does Not Suppress Inflammatory Responses to Evoked Endotoxemia. J Am Heart Assoc. 2012 Aug;1(4):e002923. doi: 10.1161/JAHA.112.002923. Epub 2012 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muredach P Reilly, MB, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate (Tricor) tablets and Lovaza in people with Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). (time frame: randomization and 8 weeks post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.