Recruiting

Lovaza

Sponsor:

Brigham and Women's Hospital

Code:

NCT01301794

Conditions

Moderate Hypertriglyceridemia.

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Omega 3 fatty acid (Lovaza)

Study Details

Brief summary:

High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.

Conditions

Moderate Hypertriglyceridemia.

Study ID

NCT01301794

Start date

Aug, 2012

Status verified date

Feb, 2013

Completion date

Aug, 2014

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Otherwise healthy 21 to 65 year old men and women
  • Triglycerides >150 < 500 mg/dL

Exclusion Criteria:

  • Other lipid lowering medication including fish oil
  • Major illnesses
  • Diabetes
  • Cardiovascular disease
  • Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides > 500 mg/dL
  • Indication for immediate statin therapy
  • Pregnancy
  • Contraindication for fish oil use or muscle biopsy

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

Omega 3 fatty acid (Lovaza)

Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).

Primary outcome measure

  • Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system. [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jorge Plutzky, MD

617-525-4360jplutzky@rics.bwh.harvard.edu

Jon Brown, MD

617-525-4360jbrown0@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sutanuka Lahiri

617-525-6823Sutanuka Lahiri <SLAHIRI@PARTNERS.ORG>

Jorge Plutzky

326-055-200jplutzky@rics.bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 25, 2013

Last verified

Feb, 2013

Keywords

  • Hypertriglyceridemia
  • Fish oil
  • Omega 3 fatty acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2013-02-25.