Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides

NCT00504309 | Completed Results

• 1 other identifier: G214
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Keywords

triglycerides; hypertriglyceridemia; omega-3; n-3; eicosapentaenoic acid; EPA; docosahexaenoic acid; DHA; flow mediated dilation; fish; Moderate hypertriglyceridemia

Outcome Measures

Primary Outcomes (4)

• Lipid Profile

  Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.

  8 weeks

• Flow-mediated Dilation (FMD)

  Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.

  8 weeks

• Blood Pressure

  Effect of P-OM3 dose on blood pressure

  8 weeks

• Heart Rate

  Effect of P-OM3 dose on heart rate

  8 weeks

Secondary Outcomes (7)

• Erythrocyte Fatty Acids

  8 weeks

• Cytokine Inflammatory Markers

  8 weeks

• Fasting Glucose

  8 weeks

• Psychosocial Profile Questionnaires

  8 weeks

• C-reactive Protein (CRP)

  8 weeks

Study Arms (6)

4g P-OM3, then 1g P-OM3, then Placebo

EXPERIMENTAL

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).

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

1g P-OM3, then 4g P-OM3, then Placebo

EXPERIMENTAL

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.

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

Placebo, then 4g P-OM3, then 1g P-OM3

EXPERIMENTAL

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.

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

4g P-OM3, then Placebo, then 1g P-OM3

EXPERIMENTAL

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.

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

1g P-OM3, then Placebo, then 4g P-OM3

EXPERIMENTAL

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.

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

Placebo, then 1g P-OM3, then 4g P-OM3

EXPERIMENTAL

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.

Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

Interventions

4/day of 4g P-OM3 capsules DRUG

4/day of 4g P-OM3 capsules for 8 weeks

Also known as: OM3AEE, Lovaza, Fish oil

1g P-OM3, then 4g P-OM3, then Placebo; 1g P-OM3, then Placebo, then 4g P-OM3; 4g P-OM3, then 1g P-OM3, then Placebo; 4g P-OM3, then Placebo, then 1g P-OM3; Placebo, then 1g P-OM3, then 4g P-OM3; Placebo, then 4g P-OM3, then 1g P-OM3

4/day of 1g P-OM3 capsules DRUG

4/day of 1g P-OM3 capsules for 8 weeks

Also known as: OM3AEE, Lovaza, Fish oil

1g P-OM3, then 4g P-OM3, then Placebo; 1g P-OM3, then Placebo, then 4g P-OM3; 4g P-OM3, then 1g P-OM3, then Placebo; 4g P-OM3, then Placebo, then 1g P-OM3; Placebo, then 1g P-OM3, then 4g P-OM3; Placebo, then 4g P-OM3, then 1g P-OM3

Corn Oil Placebo, 4 capsules/day for 8 weeks DRUG

4 capsules per day of corn oil placebo for 8 weeks

Also known as: Corn oil

1g P-OM3, then 4g P-OM3, then Placebo; 1g P-OM3, then Placebo, then 4g P-OM3; 4g P-OM3, then 1g P-OM3, then Placebo; 4g P-OM3, then Placebo, then 1g P-OM3; Placebo, then 1g P-OM3, then 4g P-OM3; Placebo, then 4g P-OM3, then 1g P-OM3

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Reliant Pharmaceuticals: collaborator

Study Sites (1)

Penn State University General Clinical Research Center

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• 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.

  PMID: 23592752 DERIVED

• 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.

  PMID: 22865498 DERIVED

• 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.

  PMID: 21159789 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor; Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Ann Skulas-Ray
• Organization: Penn State University

aus164@psu.edu

814-863-0856

Study Officials

• Sheila G West, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Penny M Kris-Etherton, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Ann C Skulas-Ray, B.S.

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biobehavioral Health

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (1)