Trial Outcomes & Findings for Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults (NCT NCT03043365)
NCT ID: NCT03043365
Last Updated: 2020-08-12
Results Overview
The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2020-08-12
Participant Flow
Thirty-seven healthy volunteers were recruited from June 2017 through March 2018 at the National Institutes of Health (NIH) (Bethesda, MD)
Participant milestones
| Measure |
Arm 1: Control Fish Oil Arm Then Saury Oil
Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and cross-over to the Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals
|
Arm 2 - Saury Oil Arm Then Control Fish Oil
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil: 4 capsules, 3 times a day after meals
|
|---|---|---|
|
Weeks 0 to Week 8
STARTED
|
20
|
17
|
|
Weeks 0 to Week 8
COMPLETED
|
17
|
14
|
|
Weeks 0 to Week 8
NOT COMPLETED
|
3
|
3
|
|
Week 8 to Week 16 - Washout Period
STARTED
|
17
|
14
|
|
Week 8 to Week 16 - Washout Period
COMPLETED
|
16
|
14
|
|
Week 8 to Week 16 - Washout Period
NOT COMPLETED
|
1
|
0
|
|
Week 16 to Week 24
STARTED
|
16
|
14
|
|
Week 16 to Week 24
COMPLETED
|
16
|
14
|
|
Week 16 to Week 24
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Control Fish Oil Arm Then Saury Oil
Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and cross-over to the Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals
|
Arm 2 - Saury Oil Arm Then Control Fish Oil
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil: 4 capsules, 3 times a day after meals
|
|---|---|---|
|
Weeks 0 to Week 8
Adverse Event
|
1
|
3
|
|
Weeks 0 to Week 8
Lost to Follow-up
|
2
|
0
|
|
Week 8 to Week 16 - Washout Period
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Baseline characteristics by cohort
| Measure |
Arm 1: Control Fish Oil First, Then Saury Oil
n=20 Participants
Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals
|
Arm 2:Saury Oil First, Then Control Fish Oil
n=17 Participants
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm LCMUFA-rich saury oil: 4 capsules, 3 times a day after meals
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
32.3 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
34.8 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksThe primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.
Outcome measures
| Measure |
Arm 1 - Control Fish Oil Arm
n=30 Participants
Subjects randomized to the control fish oil arm will take 3g of control /day (12 gel capsules/day) for 8 weeks
|
Arm 2 - Saury Oil Arm
n=30 Participants
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
|
|---|---|---|
|
Changes From Baseline in Lipid Profile at 8 Weeks
TG (mg/dL)
|
52 mg/dL
Standard Deviation 21.1
|
56.1 mg/dL
Standard Deviation 26.5
|
|
Changes From Baseline in Lipid Profile at 8 Weeks
TC (mg/dL)
|
184.3 mg/dL
Standard Deviation 45.6
|
181.7 mg/dL
Standard Deviation 50.9
|
|
Changes From Baseline in Lipid Profile at 8 Weeks
HDL-C (mg/dL)
|
67.9 mg/dL
Standard Deviation 16.9
|
68.7 mg/dL
Standard Deviation 19.7
|
|
Changes From Baseline in Lipid Profile at 8 Weeks
LDL-C (mg/dL)
|
102.7 mg/dL
Standard Deviation 45.2
|
98.6 mg/dL
Standard Deviation 50.6
|
SECONDARY outcome
Timeframe: baseline and 8 weeksSecondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).
Outcome measures
| Measure |
Arm 1 - Control Fish Oil Arm
n=30 Participants
Subjects randomized to the control fish oil arm will take 3g of control /day (12 gel capsules/day) for 8 weeks
|
Arm 2 - Saury Oil Arm
n=30 Participants
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
|
|---|---|---|
|
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
ApoB (mg/dL)
|
91.4 mg/dL
Standard Deviation 31.1
|
89 mg/dL
Standard Deviation 33.8
|
|
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
sdLDL (mg/dL)
|
29.7 mg/dL
Standard Deviation 16.4
|
29 mg/dL
Standard Deviation 17.9
|
|
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
LDL-TG (mg/dL)
|
14.4 mg/dL
Standard Deviation 6.3
|
14.7 mg/dL
Standard Deviation 5.7
|
|
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
ApoE-HDL (mg/dL)
|
6.3 mg/dL
Standard Deviation 1.7
|
6.5 mg/dL
Standard Deviation 2.1
|
|
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
ApoA-I (mg/dL)
|
158.3 mg/dL
Standard Deviation 26.8
|
156.1 mg/dL
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: baseline and 8 weeksSecondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.
Outcome measures
| Measure |
Arm 1 - Control Fish Oil Arm
n=30 Participants
Subjects randomized to the control fish oil arm will take 3g of control /day (12 gel capsules/day) for 8 weeks
|
Arm 2 - Saury Oil Arm
n=30 Participants
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
|
|---|---|---|
|
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)
|
75.3 U/L
Standard Deviation 24.8
|
72.9 U/L
Standard Deviation 26.1
|
Adverse Events
Arm 1: Control Fish Oil Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2: Saury Oil Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Control Fish Oil Arm
n=34 participants at risk
Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks
|
Arm 2: Saury Oil Arm
n=33 participants at risk
Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
|
Washout Period
n=31 participants at risk
No intervention administer to participants.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
2.9%
1/34 • Number of events 1 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/34 • 24 weeks
|
3.0%
1/33 • Number of events 1 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
|
Surgical and medical procedures
Skin biopsy of left leg
|
2.9%
1/34 • Number of events 1 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • 24 weeks
|
3.0%
1/33 • Number of events 1 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
|
Injury, poisoning and procedural complications
Toe Injury
|
0.00%
0/34 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
3.2%
1/31 • Number of events 1 • 24 weeks
|
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