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CompletedNCT00504309OMEGAUpdated Mar 13, 2018Results posted

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

An interventional study of 4/day of 4g P-OM3 capsules and 4/day of 1g P-OM3 capsules in Hypertriglyceridemia, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Penn State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertriglyceridemia

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Keywords

  • triglycerides
  • hypertriglyceridemia
  • omega-3
  • n-3
  • eicosapentaenoic acid
  • EPA
  • docosahexaenoic acid
  • DHA
  • flow mediated dilation
  • fish
  • Moderate hypertriglyceridemia
03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 28 is below the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    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).

    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

  • Experimental
    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.

    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

  • Experimental
    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.

    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

  • Experimental
    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.

    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

  • Experimental
    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.

    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

  • Experimental
    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.

    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

  • Drug4/day of 4g P-OM3 capsules

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

    Also known as: OM3AEE, Lovaza, Fish oil

  • Drug4/day of 1g P-OM3 capsules

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

    Also known as: OM3AEE, Lovaza, Fish oil

  • DrugCorn Oil Placebo, 4 capsules/day for 8 weeks

    4 capsules per day of corn oil placebo for 8 weeks

    Also known as: Corn oil

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. Blood Pressure

    Effect of P-OM3 dose on blood pressure

    Time frame: 8 weeks

  4. Heart Rate

    Effect of P-OM3 dose on heart rate

    Time frame: 8 weeks

Secondary outcomes

  1. Erythrocyte Fatty Acids

    Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells

    Time frame: 8 weeks

  2. Cytokine Inflammatory Markers

    Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma

    Time frame: 8 weeks

  3. Fasting Glucose

    Effect of P-OM3 dose on fasting glucose

    Time frame: 8 weeks

  4. Psychosocial Profile Questionnaires

    Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS) * 14 questions, scored 0-4 based on how often the subject felt certain emotions * Scores: 0 to 40; higher scores indicate higher perceived stress Spielberger State Anxiety Inventory * Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale * Scores: 20 to 80; higher scores indicate higher levels of anxiety Positive and Negative Affect Scales (PANAS) * Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much). * Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect Center for Epidemiologic Studies Depression (CES-D) Scale * 20 questions about symptoms of depression in the past week * Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional

    Time frame: 8 weeks

  5. C-reactive Protein (CRP)

    Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP

    Time frame: 8 weeks

  6. Fasting Insulin

    Effect of P-OM3 dose on fasting insulin

    Time frame: 8 weeks

  7. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)

    Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL \* insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)).

    Time frame: 8 weeks

07

Results

Posted Mar 13, 2018

Participant flow

Participant flow — Overall Study
Milestone4g P-OM3, Then 1g P-OM3, Then Placebo1g P-OM3, Then 4g P-OM3, Then PlaceboPlacebo, Then 4g P-OM3, Then 1g P-OM34g P-OM3, Then Placebo, Then 1g P-OM31g P-OM3, Then Placebo, Then 4g P-OM3Placebo, Then 1g P-OM3, Then 4g P-OM3
Started752383
Completed751373
Not completed001010
Withdrew: Death000010
Withdrew: Withdrawal by subject001000

Outcome measures

PrimaryLipid 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.

Time frame:
8 weeks
Reported as:
Mean · mg/dL
Lipid Profile
mg/dL4g P-OM31g P-OM3Placebo
High density lipoprotein-cholesterol (HDL-C)43.2 ± 1.942.7 ± 1.942.6 ± 1.9
Low density lipoprotein-cholesterol (LDL-C)130.3 ± 7.6127.6 ± 7.6123.3 ± 7.6
Total Cholesterol207.9 ± 7.9212.1 ± 7.9209 ± 7.9
Triglycerides173.7 ± 17.5215.3 ± 17.5237.3 ± 17.5
Statistical analysis
  • 4g P-OM3 vs 1g P-OM3 vs Placebo · Mixed Models Analysis · p = 0.002Tukey p-values were used for post hoc comparisons.
  • 4g P-OM3 vs 1g P-OM3 vs Placebo · Mixed Models Analysis · p = > 0.05
PrimaryFlow-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.

Time frame:
8 weeks
Reported as:
Mean · % change in brachial artery diameter
Flow-mediated Dilation (FMD)
% change in brachial artery diameter4g P-OM31g P-OM3Placebo
Flow-mediated Dilation (FMD)5.00 ± 0.54.03 ± 0.55.00 ± 0.5
PrimaryBlood Pressure

Effect of P-OM3 dose on blood pressure

Time frame:
8 weeks
Reported as:
Mean · mm Hg
Blood Pressure
mm Hg4g P-OM31g P-OM3Placebo
Diastolic blood pressure (DBP)76.1 ± 1.677.7 ± 1.677.8 ± 1.6
Systolic blood pressure (SBP)126.3 ± 2.2129.0 ± 2.2128.4 ± 2.2
PrimaryHeart Rate

Effect of P-OM3 dose on heart rate

Time frame:
8 weeks
Reported as:
Mean · beats per minute
Heart Rate
beats per minute4g P-OM31g P-OM3Placebo
Heart Rate67.9 ± 1.869.8 ± 1.871.8 ± 1.8
SecondaryErythrocyte Fatty Acids

Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells

Time frame:
8 weeks
Reported as:
Mean · percentage
Erythrocyte Fatty Acids
percentage4g P-OM31g P-OM3Placebo
Eicosapentaenoic acid (EPA)2.30 ± 0.091.15 ± 0.090.57 ± 0.09
Docosahexaenoic acid (DHA)6.49 ± 0.155.34 ± 0.154.39 ± 0.15
Omega-3 Index (EPA + DHA)8.79 ± 0.216.49 ± 0.214.96 ± 0.21
SecondaryCytokine Inflammatory Markers

Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma

Time frame:
8 weeks
Reported as:
Mean · pg/mL
Cytokine Inflammatory Markers
pg/mL4g P-OM31g P-OM3Placebo
Interleuken-1β (IL-1β)0.14 ± 0.020.15 ± 0.020.15 ± 0.02
Interleuken-6 (IL-6)0.87 ± 0.150.85 ± 0.150.87 ± 0.15
Tumor Necrosis Factor-α (TNF-α)1.00 ± 0.071.11 ± 0.141.20 ± 0.14
SecondaryFasting Glucose

Effect of P-OM3 dose on fasting glucose

Time frame:
8 weeks
Reported as:
Mean · mg/dL
Fasting Glucose
mg/dL4g P-OM31g P-OM3Placebo
Fasting Glucose99.2 ± 1.998.0 ± 1.996.1 ± 2.0
SecondaryPsychosocial Profile Questionnaires

Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS) * 14 questions, scored 0-4 based on how often the subject felt certain emotions * Scores: 0 to 40; higher scores indicate higher perceived stress Spielberger State Anxiety Inventory * Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale * Scores: 20 to 80; higher scores indicate higher levels of anxiety Positive and Negative Affect Scales (PANAS) * Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much). * Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect Center for Epidemiologic Studies Depression (CES-D) Scale * 20 questions about symptoms of depression in the past week * Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional

Time frame:
8 weeks
Reported as:
Mean · scores on a scale
Psychosocial Profile Questionnaires
scores on a scale4g P-OM31g P-OM3Placebo
Perceived Stress Scale (PSS)23.2 ± 2.223.7 ± 2.422.3 ± 2.3
Positive Scale (PANAS)34.1 ± 2.235.0 ± 2.435.2 ± 2.3
Negative Scale (PANAS)11.7 ± 2.413.3 ± 2.511.9 ± 2.4
CES-D3.4 ± 2.93.3 ± 3.12.2 ± 3.0
Spielberger State Anxiety Inventory46.2 ± 1.546.5 ± 1.645.0 ± 1.6
SecondaryC-reactive Protein (CRP)

Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP

Time frame:
8 weeks
Reported as:
Mean · mg/L
C-reactive Protein (CRP)
mg/L4g P-OM31g P-OM3Placebo
C-reactive Protein (CRP)1.29 ± 0.21.32 ± 0.21.45 ± 0.2
SecondaryFasting Insulin

Effect of P-OM3 dose on fasting insulin

Time frame:
8 weeks
Reported as:
Mean · μIU/mL
Fasting Insulin
μIU/mL4g P-OM31g P-OM3Placebo
Fasting Insulin15.0 ± 1.415.5 ± 1.414.6 ± 1.4
SecondaryHomeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)

Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL \* insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)).

Time frame:
8 weeks
Reported as:
Mean · index units
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
index units4g P-OM31g P-OM3Placebo
HOMA-IR3.64 ± 0.43.75 ± 0.43.55 ± 0.4
QUICKI0.14 ± 0.0020.14 ± 0.0020.14 ± 0.002

Adverse events

Collected over Adverse event data were collected while participants were enrolled (approximately 2.5 years).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
4g P-OM3—0/27 (0%)1/27 (3.7%)
1g P-OM3—0/27 (0%)0/27 (0%)
Placebo—0/28 (0%)0/28 (0%)
Most frequent other events
Most frequent other events
Event4g P-OM31g P-OM3Placebo
Gastrointestinal symptomsGastrointestinal disorders1/270/270/28

Baseline characteristics

1 subject in the "Placebo, 4 g P-OM3, 1 g P-OM3" sequence and 1 subject in the "1 g P-OM3, Placebo, 4 g P-OM3" sequence did not complete the study and were not included in the baseline analysis.

Age, Categorical
Age, Categorical(Participants)4 g P-OM3, 1 g P-OM3, Placebo1 g P-OM3, 4 g P-OM3, PlaceboPlacebo, 4 g P-OM3, 1 g P-OM34 g P-OM3, Placebo, 1 g P-OM31 g P-OM3, Placebo, 4 g P-OM3Placebo, 1 g P-OM3, 4 g P-OM3Total
<=18 years0000000
Between 18 and 65 years74137325
>=65 years0100001
Sex: Female, Male
Sex: Female, Male(Participants)4 g P-OM3, 1 g P-OM3, Placebo1 g P-OM3, 4 g P-OM3, PlaceboPlacebo, 4 g P-OM3, 1 g P-OM34 g P-OM3, Placebo, 1 g P-OM31 g P-OM3, Placebo, 4 g P-OM3Placebo, 1 g P-OM3, 4 g P-OM3Total
Female0100203
Male74135323
Region of Enrollment
Region of Enrollment(participants)4 g P-OM3, 1 g P-OM3, Placebo1 g P-OM3, 4 g P-OM3, PlaceboPlacebo, 4 g P-OM3, 1 g P-OM34 g P-OM3, Placebo, 1 g P-OM31 g P-OM3, Placebo, 4 g P-OM3Placebo, 1 g P-OM3, 4 g P-OM3Total
United States75137326
08

Study locations

1 site
  • Penn State University General Clinical Research Center
    University Park, Pennsylvania 16802, United States
09

References and documents

Publications

  • 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. PubMed 23592752 ↗
  • 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. PubMed 22865498 ↗
  • 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. PubMed 21159789 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00504309
Lead sponsor
Penn State University
Collaborators
Reliant Pharmaceuticals
Responsible party
Sheila G West (Professor of Biobehavioral Health, Penn State University) — Principal investigator
First posted
Jul 20, 2007
Start date
Jul 2007
Primary completion
Jan 2009
Completion
Jan 2009
Results posted
Mar 13, 2018
Last update
Mar 13, 2018

Study contacts

Sheila G West, PhD
principal investigator · Penn State University
Penny M Kris-Etherton, PhD
principal investigator · Penn State University
Ann C Skulas-Ray, B.S.
principal investigator · Penn State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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