Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
NCT ID: NCT00504309
Last Updated: 2018-03-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2007-07-31
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
NCT02305355
The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes
NCT00360217
Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction
NCT01422317
Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
NCT01086163
Effect of Omega-3 Fatty Acid on Endothelial Function
NCT01813006
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
4g P-OM3, then 1g P-OM3, then Placebo
4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
1g P-OM3, then 4g P-OM3, then Placebo
1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
4g P-OM3, then Placebo, then 1g P-OM3
4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
1g P-OM3, then Placebo, then 4g P-OM3
1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Placebo, then 1g P-OM3, then 4g P-OM3
Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age 21-65 years
* generally healthy
* body mass index (BMI) 20-39 kg/m2
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Reliant Pharmaceuticals
INDUSTRY
Penn State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sheila G West
Professor of Biobehavioral Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sheila G West, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Penny M Kris-Etherton, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Ann C Skulas-Ray, B.S.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State University General Clinical Research Center
University Park, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G214
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.