Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Condition: Lipoprotein Metabolism; PCSK9; Proteomics
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): control fish oil; LCMUFA-rich saury oil
Intervention type(s): Drug; Drug
Intervention description(s): 4 capsules, 3 times a day after meals; 4 capsules, 3 times a day after meals
Other intervention name(s): DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils); fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,; PUFA, W3 fatty acids; long-chain monounsaturated fatty acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fish Oils; Long Chain Monounsaturated Fatty Acids (LCMUFA); Lipoproteins; Cardiovascular Disease