Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
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|ClinicalTrials.gov Identifier: NCT03043365|
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
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.
To understand the effects of LCMUFA from fish oil on cardiovascular health.
Healthy volunteers ages 18 and older with no history of cardiovascular disease
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.
|Condition or disease||Intervention/treatment||Phase|
|Lipoprotein Metabolism PCSK9 Proteomics||Drug: control fish oil Drug: LCMUFA-rich saury oil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults|
|Actual Study Start Date :||June 15, 2017|
|Actual Primary Completion Date :||May 29, 2019|
|Actual Study Completion Date :||November 21, 2019|
Experimental: Arm 1: Control Fish Oil first, 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 crossover to the LCMUFA-rich saury oil capsule arm
Drug: control fish oil
4 capsules, 3 times a day after meals
Experimental: Arm 2: Saury Oil first, 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
Drug: LCMUFA-rich saury oil
4 capsules, 3 times a day after meals
Other Name: long-chain monounsaturated fatty acids
No Intervention: Washout Period
8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time.
- Changes From Baseline in Lipid Profile at 8 Weeks [ Time Frame: 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.
- Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043365
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Marcelo J Amar, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|