Clinical trial NCT00504309: Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
Official title: Omacor: Measures of Endothelial Function and triGlyceride Alteration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: triglycerides
hypertriglyceridemia
omega-3
n-3
eicosapentaenoic acid
EPA
docosahexaenoic acid
DHA
flow mediated dilation
fish
Moderate hypertriglyceridemia
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Reliant Pharmaceuticals
First posted: 2007-07-20
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.


Eligibility criteria: Inclusion Criteria:

* triglycerides 150-500 mg/dL
* age 21-65 years
* generally healthy
* body mass index (BMI) 20-39 kg/m2

Exclusion Criteria:

* smoking
* premenopausal (if female)
* use of hormone replacement or oral contraceptives
* use of lipid lowering or blood pressure medication
* hypertension (blood pressure \> 150/95 mm Hg)
* peripheral vascular disease
* heart disease, diabetes, or stroke
* inflammatory disease (e.g. rheumatoid arthritis or Crohn's)
* elevated liver enzymes
* high intake of omega-3 containing foods
* allergy to adhesive or latex
* use of aspirin, anticoagulants, or SSRI

Primary outcomes:
measure: Lipid Profile
timeFrame: 8 weeks
measure: Flow-mediated Dilation (FMD)
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Heart Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Erythrocyte Fatty Acids
timeFrame: 8 weeks
measure: Cytokine Inflammatory Markers
timeFrame: 8 weeks
measure: Fasting Glucose
timeFrame: 8 weeks
measure: Psychosocial Profile Questionnaires
timeFrame: 8 weeks
measure: C-reactive Protein (CRP)
timeFrame: 8 weeks
measure: Fasting Insulin
timeFrame: 8 weeks
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University General Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Sheila G West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Ann C Skulas-Ray, B.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sauder KA, Skulas-Ray AC, Campbell TS, Johnson JA, Kris-Etherton PM, West SG. Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia. Psychosom Med. 2013 May;75(4):382-9. doi: 10.1097/PSY.0b013e318290a107. Epub 2013 Apr 16.
citation: Skulas-Ray AC, Kris-Etherton PM, Harris WS, West SG. Effects of marine-derived omega-3 fatty acids on systemic hemodynamics at rest and during stress: a dose-response study. Ann Behav Med. 2012 Dec;44(3):301-8. doi: 10.1007/s12160-012-9393-2.
citation: Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15.