Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults

Phase 2

Completed

Conditions: Proteomics
Lipoprotein Metabolism
PCSK9

Interventions: Drug: control fish oil
Drug: LCMUFA-rich saury oil

Registration Number: NCT03043365

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary: 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.

Detailed Description: Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty acids over 18 carbons in length with a single double bond, have been shown in mice to decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study will test the hypothesis that LCMUFA supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be affected by supplementation with omega-3 fatty acids.

This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: Control Fish Oil first, then Saury Oil	control fish 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 crossover to the LCMUFA-rich saury oil capsule arm
Arm 2: Saury Oil first, then Control Fish Oil	LCMUFA-rich saury 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

Primary Outcome Measures

Name	Time	Method
Changes From Baseline in Lipid Profile at 8 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)	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).
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)	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.