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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Hypertriglyceridemia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00504309

G214

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 6 patient groups

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

Experimental group

Description:

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).

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

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

Experimental group

Description:

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.

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

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

Experimental group

Description:

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.

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

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

Experimental group

Description:

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.

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

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

Experimental group

Description:

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.

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

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

Experimental group

Description:

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.

Treatment:

Drug: 4/day of 1g P-OM3 capsules

Drug: 4/day of 4g P-OM3 capsules

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks