Trial Outcomes & Findings for Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides (NCT NCT00504309)
NCT ID: NCT00504309
Last Updated: 2018-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-03-13
Participant Flow
Participant milestones
| Measure |
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)
|
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
|
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
|
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
|
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.
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
2
|
3
|
8
|
3
|
|
Overall Study
COMPLETED
|
7
|
5
|
1
|
3
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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)
|
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
|
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
|
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
|
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.
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
Baseline characteristics by cohort
| Measure |
4 g P-OM3, 1 g P-OM3, Placebo
n=7 Participants
4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
|
1 g P-OM3, 4 g P-OM3, Placebo
n=5 Participants
1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
|
Placebo, 4 g P-OM3, 1 g P-OM3
n=1 Participants
4 g/d corn oil placebo for 8 weeks, followed by 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
|
4 g P-OM3, Placebo, 1 g P-OM3
n=3 Participants
4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
|
1 g P-OM3, Placebo, 4 g P-OM3
n=7 Participants
1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
|
Placebo, 1 g P-OM3, 4 g P-OM3
n=3 Participants
4 g/d corn oil placebo for 8 weeks, followed by 1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
3 participants
n=10 Participants
|
26 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPlasma/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.
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Lipid Profile
High density lipoprotein-cholesterol (HDL-C)
|
43.2 mg/dL
Standard Error 1.9
|
42.7 mg/dL
Standard Error 1.9
|
42.6 mg/dL
Standard Error 1.9
|
|
Lipid Profile
Low density lipoprotein-cholesterol (LDL-C)
|
130.3 mg/dL
Standard Error 7.6
|
127.6 mg/dL
Standard Error 7.6
|
123.3 mg/dL
Standard Error 7.6
|
|
Lipid Profile
Total Cholesterol
|
207.9 mg/dL
Standard Error 7.9
|
212.1 mg/dL
Standard Error 7.9
|
209 mg/dL
Standard Error 7.9
|
|
Lipid Profile
Triglycerides
|
173.7 mg/dL
Standard Error 17.5
|
215.3 mg/dL
Standard Error 17.5
|
237.3 mg/dL
Standard Error 17.5
|
PRIMARY outcome
Timeframe: 8 weeksEffect 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.
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Flow-mediated Dilation (FMD)
|
5.00 % change in brachial artery diameter
Standard Error 0.5
|
4.03 % change in brachial artery diameter
Standard Error 0.5
|
5.00 % change in brachial artery diameter
Standard Error 0.5
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Two participants did not complete the study and were therefore excluded from analysis.
Effect of P-OM3 dose on blood pressure
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Blood Pressure
Systolic blood pressure (SBP)
|
126.3 mm Hg
Standard Error 2.2
|
129.0 mm Hg
Standard Error 2.2
|
128.4 mm Hg
Standard Error 2.2
|
|
Blood Pressure
Diastolic blood pressure (DBP)
|
76.1 mm Hg
Standard Error 1.6
|
77.7 mm Hg
Standard Error 1.6
|
77.8 mm Hg
Standard Error 1.6
|
PRIMARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on heart rate
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Heart Rate
|
67.9 beats per minute
Standard Error 1.8
|
69.8 beats per minute
Standard Error 1.8
|
71.8 beats per minute
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Erythrocyte Fatty Acids
Eicosapentaenoic acid (EPA)
|
2.30 percentage
Standard Error 0.09
|
1.15 percentage
Standard Error 0.09
|
0.57 percentage
Standard Error 0.09
|
|
Erythrocyte Fatty Acids
Docosahexaenoic acid (DHA)
|
6.49 percentage
Standard Error 0.15
|
5.34 percentage
Standard Error 0.15
|
4.39 percentage
Standard Error 0.15
|
|
Erythrocyte Fatty Acids
Omega-3 Index (EPA + DHA)
|
8.79 percentage
Standard Error 0.21
|
6.49 percentage
Standard Error 0.21
|
4.96 percentage
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Cytokine Inflammatory Markers
Interleuken-1β (IL-1β)
|
0.14 pg/mL
Standard Error 0.02
|
0.15 pg/mL
Standard Error 0.02
|
0.15 pg/mL
Standard Error 0.02
|
|
Cytokine Inflammatory Markers
Interleuken-6 (IL-6)
|
0.87 pg/mL
Standard Error 0.15
|
0.85 pg/mL
Standard Error 0.15
|
0.87 pg/mL
Standard Error 0.15
|
|
Cytokine Inflammatory Markers
Tumor Necrosis Factor-α (TNF-α)
|
1.00 pg/mL
Standard Error 0.07
|
1.11 pg/mL
Standard Error 0.14
|
1.20 pg/mL
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on fasting glucose
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Fasting Glucose
|
99.2 mg/dL
Standard Error 1.9
|
98.0 mg/dL
Standard Error 1.9
|
96.1 mg/dL
Standard Error 2.0
|
SECONDARY outcome
Timeframe: 8 weeksEffect 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
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Psychosocial Profile Questionnaires
Perceived Stress Scale (PSS)
|
23.2 scores on a scale
Standard Error 2.2
|
23.7 scores on a scale
Standard Error 2.4
|
22.3 scores on a scale
Standard Error 2.3
|
|
Psychosocial Profile Questionnaires
Positive Scale (PANAS)
|
34.1 scores on a scale
Standard Error 2.2
|
35.0 scores on a scale
Standard Error 2.4
|
35.2 scores on a scale
Standard Error 2.3
|
|
Psychosocial Profile Questionnaires
Negative Scale (PANAS)
|
11.7 scores on a scale
Standard Error 2.4
|
13.3 scores on a scale
Standard Error 2.5
|
11.9 scores on a scale
Standard Error 2.4
|
|
Psychosocial Profile Questionnaires
CES-D
|
3.4 scores on a scale
Standard Error 2.9
|
3.3 scores on a scale
Standard Error 3.1
|
2.2 scores on a scale
Standard Error 3.0
|
|
Psychosocial Profile Questionnaires
Spielberger State Anxiety Inventory
|
46.2 scores on a scale
Standard Error 1.5
|
46.5 scores on a scale
Standard Error 1.6
|
45.0 scores on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
C-reactive Protein (CRP)
|
1.29 mg/L
Standard Error 0.2
|
1.32 mg/L
Standard Error 0.2
|
1.45 mg/L
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 8 weeksEffect of P-OM3 dose on fasting insulin
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Fasting Insulin
|
15.0 μIU/mL
Standard Error 1.4
|
15.5 μIU/mL
Standard Error 1.4
|
14.6 μIU/mL
Standard Error 1.4
|
SECONDARY outcome
Timeframe: 8 weeksEffect 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)).
Outcome measures
| Measure |
4g P-OM3
n=26 Participants
4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=26 Participants
1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=26 Participants
4 g/d corn oil placebo
|
|---|---|---|---|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
HOMA-IR
|
3.64 index units
Standard Error 0.4
|
3.75 index units
Standard Error 0.4
|
3.55 index units
Standard Error 0.4
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
QUICKI
|
0.14 index units
Standard Error 0.002
|
0.14 index units
Standard Error 0.002
|
0.14 index units
Standard Error 0.002
|
Adverse Events
4g P-OM3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1g P-OM3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4g P-OM3
n=27 participants at risk
4 g Prescription Omega-3 acid ethyl esters (P-OM3)
|
1g P-OM3
n=27 participants at risk
1 g Prescription Omega-3 acid ethyl esters (P-OM3)
|
Placebo
n=28 participants at risk
Corn oil placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected while participants were enrolled (approximately 2.5 years).
|
0.00%
0/27 • Adverse event data were collected while participants were enrolled (approximately 2.5 years).
|
0.00%
0/28 • Adverse event data were collected while participants were enrolled (approximately 2.5 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place