N/A
N=28
Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT00504309 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Lipid Profile — 43.2; 42.7; 42.6; 130.3 mg/dL — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lipid Profile |
43.2; 42.7; 42.6; 130.3; 127.6; 123.3 | 0.002 sig |
| PRIMARY Flow-mediated Dilation (FMD) |
5.00; 4.03; 5.00 | — |
| PRIMARY Blood Pressure |
76.1; 77.7; 77.8; 126.3; 129.0; 128.4 | — |
| PRIMARY Heart Rate |
67.9; 69.8; 71.8 | — |
| SECONDARY Erythrocyte Fatty Acids |
2.30; 1.15; 0.57; 6.49; 5.34; 4.39 | — |
| SECONDARY Cytokine Inflammatory Markers |
0.14; 0.15; 0.15; 0.87; 0.85; 0.87 | — |
| SECONDARY Fasting Glucose |
99.2; 98.0; 96.1 | — |
| SECONDARY Psychosocial Profile Questionnaires |
23.2; 23.7; 22.3; 34.1; 35.0; 35.2 | — |
| SECONDARY C-reactive Protein (CRP) |
1.29; 1.32; 1.45 | — |
| SECONDARY Fasting Insulin |
15.0; 15.5; 14.6 | — |
| SECONDARY Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) |
3.64; 3.75; 3.55; 0.14; 0.14; 0.14 | — |
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
Data sourced from ClinicalTrials.gov (NCT00504309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.