Adults 18 to 100, any sex, with Lipoprotein Metabolism or PCSK9. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes From Baseline in Lipid Profile at 8 WeeksPrimary· baseline and 8 weeks
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.
TG (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
52
± 21.1
Arm 2 - Saury Oil Arm
56.1
± 26.5
TC (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
184.3
± 45.6
Arm 2 - Saury Oil Arm
181.7
± 50.9
HDL-C (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
67.9
± 16.9
Arm 2 - Saury Oil Arm
68.7
± 19.7
LDL-C (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
102.7
± 45.2
Arm 2 - Saury Oil Arm
98.6
± 50.6
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)Secondary· baseline and 8 weeks
Secondary 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).
sdLDL (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
29.7
± 16.4
Arm 2 - Saury Oil Arm
29
± 17.9
LDL-TG (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
14.4
± 6.3
Arm 2 - Saury Oil Arm
14.7
± 5.7
ApoE-HDL (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
6.3
± 1.7
Arm 2 - Saury Oil Arm
6.5
± 2.1
ApoA-I (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
158.3
± 26.8
Arm 2 - Saury Oil Arm
156.1
± 30.4
ApoB (mg/dL)
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
91.4
± 31.1
Arm 2 - Saury Oil Arm
89
± 33.8
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)Secondary· baseline and 8 weeks
Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.
Group
Value
95% CI
Arm 1 - Control Fish Oil Arm
75.3
± 24.8
Arm 2 - Saury Oil Arm
72.9
± 26.1
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market. LCMUFA (long-chain monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish oil and understand its effect on cardiovascular health.
Objective:
To understand the effects of LCMUFA from fish oil on cardiovascular health.
Eligibility:
Healthy volunteers ages 18 and older with no history of cardiovascular disease
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Fasting blood and urine tests
* Optional stool sample
* Questions about their diet, exercise, and the types of medicines and dietary supplements they take
* 7-day food diary
* Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The heart is monitored.
* After the screening visit, participants will take 4 gel capsules, 3 times a day after meals, for 8-10 weeks.
* Electrocardiogram (EKG)
Participants will have 3 additional visits. All include repeats of the screening tests.
Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for 8 weeks after this visit.
Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4 capsules, 3 times a day after meals, for 8 weeks after this visit.
Visit 4 is 8 weeks after starting the second supplement.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 12 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03043365.