Trial Outcomes & Findings for Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults (NCT NCT02514070)
NCT ID: NCT02514070
Last Updated: 2021-07-15
Results Overview
Measure plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) level, at baseline, after 6 weeks of Eicosapentaenoic acid (EPA) or Docosahexaenoic acid (DHA) fish oil supplementation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
baseline to 6 weeks of intervention
Results posted on
2021-07-15
Participant Flow
44 participants enrolled on protocol. 5 of these 44 participants were considered screen failures. 39 participants started the protocol.
Participant milestones
| Measure |
Arm 1: EPA-rich Fish Oil Then DHA-rich Fish Oil
Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
Arm 2: DHA-rich Fish Oil Then EPA-rich Fish Oil
Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
|---|---|---|
|
Weeks 0 to Week 6
STARTED
|
19
|
20
|
|
Weeks 0 to Week 6
COMPLETED
|
17
|
16
|
|
Weeks 0 to Week 6
NOT COMPLETED
|
2
|
4
|
|
Week 6 to Week 14 - Washout Period
STARTED
|
17
|
16
|
|
Week 6 to Week 14 - Washout Period
COMPLETED
|
17
|
16
|
|
Week 6 to Week 14 - Washout Period
NOT COMPLETED
|
0
|
0
|
|
Week 14 to Week 20
STARTED
|
17
|
16
|
|
Week 14 to Week 20
COMPLETED
|
16
|
14
|
|
Week 14 to Week 20
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
Baseline characteristics by cohort
| Measure |
Arm 1: EPA-rich Fish Oil, Then DHA-rich Fish Oil
n=19 Participants
Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
Arm 2: DHA-rich Fish Oil, Then EPA-rich Fish Oil
n=20 Participants
Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
34 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
32 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 weeks of interventionMeasure plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) level, at baseline, after 6 weeks of Eicosapentaenoic acid (EPA) or Docosahexaenoic acid (DHA) fish oil supplementation.
Outcome measures
| Measure |
Baseline
n=30 Participants
All study participants.
|
EPA-rich Fish Oil
n=30 Participants
Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
DHA-rich Fish Oil Arm
n=30 Participants
Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
|---|---|---|---|
|
Plasma PCSK9 Levels at Baseline and End of 6 Week Intervention
|
13.30 ng/mL
Standard Deviation 3.62
|
14.11 ng/mL
Standard Deviation 4.36
|
12.44 ng/mL
Standard Deviation 3.48
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks of interventionMeasure plasma levels at baseline to 6 weeks of intervention for the following: triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), lipoprotein particle composition and size, and high-density lipoprotein (HDL) cholesterol efflux capacity.
Outcome measures
| Measure |
Baseline
n=30 Participants
All study participants.
|
EPA-rich Fish Oil
n=30 Participants
Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
DHA-rich Fish Oil Arm
n=30 Participants
Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
|
|---|---|---|---|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
Triglyceride (TG)
|
95.3 mg/dL
Standard Deviation 66.6
|
81.7 mg/dL
Standard Deviation 64.2
|
82.1 mg/dL
Standard Deviation 57.9
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
Total Cholesterol (TC)
|
190.9 mg/dL
Standard Deviation 52.7
|
191.1 mg/dL
Standard Deviation 49.5
|
193.5 mg/dL
Standard Deviation 54.4
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
LDL-C
|
110.1 mg/dL
Standard Deviation 49.6
|
111.4 mg/dL
Standard Deviation 49.8
|
113.8 mg/dL
Standard Deviation 52.5
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
Direct LDL-C
|
115.7 mg/dL
Standard Deviation 48.6
|
114.8 mg/dL
Standard Deviation 51.3
|
120.6 mg/dL
Standard Deviation 49.6
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
Small Dense LDL
|
36.1 mg/dL
Standard Deviation 19.9
|
37.3 mg/dL
Standard Deviation 22.9
|
39.1 mg/dL
Standard Deviation 23.6
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
LDL-TG
|
13.1 mg/dL
Standard Deviation 4
|
12.9 mg/dL
Standard Deviation 4.3
|
12.8 mg/dL
Standard Deviation 4
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
HDL-C
|
62 mg/dL
Standard Deviation 18.9
|
63.4 mg/dL
Standard Deviation 20.2
|
63.4 mg/dL
Standard Deviation 20.4
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
Direct HDL-C
|
62.4 mg/dL
Standard Deviation 16.8
|
60 mg/dL
Standard Deviation 14.8
|
63.9 mg/dL
Standard Deviation 17.7
|
|
Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks
ApoE-HDL
|
5.6 mg/dL
Standard Deviation 1.8
|
5.4 mg/dL
Standard Deviation 1.6
|
5.9 mg/dL
Standard Deviation 1.9
|
Adverse Events
EPA-rich Fish Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DHA-rich Fish Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marcelo J. Amar, M.D. Principal Investigator, NIH, NHLBI
National Heart Lung and Blood Institute (NHLBI)
Phone: 301-402-0521
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place