Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Condition: Lipoprotein Metabolism; PCSK9; Proteomics
Intervention: control fish oil; LCMUFA-rich saury oil
Intervention description: 4 capsules, 3 times a day after meals; 4 capsules, 3 times a day after meals
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fish Oils; Long Chain Monounsaturated Fatty Acids (LCMUFA); Lipoproteins; Cardiovascular Disease

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Male and female participants 18 years of age or above.

          -  Subject must be healthy, with no known history of cardiovascular disease.

          -  Pre-menopausal or women of childbearing potential must be non-lactating and using an
             effective form of birth control during the course of the study.

          -  Subject understands protocol and provides written, informed consent in addition to a
             willingness to comply with specified follow-up evaluations.

        EXCLUSION CRITERIA:

          -  Pregnancy, planned pregnancy (within the study period) or women currently
             breastfeeding.

          -  Subjects with weight changes greater than 20% over the past 3 months.

          -  Subjects planning a significant change in diet or exercise levels.

          -  Subjects already consuming more than 1.5 g per day of eicosapentaenoic acid (EPA) or
             docosahexaenoic acid (DHA) in any form.

          -  Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements

          -  Subjects with known bleeding disorders (for example, Hemophilia)

          -  Subjects previously diagnosed with atrial fibrillation

          -  Subjects with clinically diagnosed hepatic disease (including but not limited to auto
             immune disease, hepatitis and cirrhosis)

          -  Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel
             motility problems, or other conditions that could affect intestinal fat absorption

          -  Subjects with any acute and life-threatening condition, such as prior sudden cardiac
             arrest, acute myocardial infarction (last three months), stroke, embolism

          -  Liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT))
             levels above 3x upper limit of normal

          -  Subjects with a thyroid-stimulating hormone (TSH) greater than 1.5x upper limits of
             normal (ULN) or clinical evidence of hypo or hyperthyroidism

          -  Subjects taking supplements or medications that affect lipoproteins for at least the
             past 8 weeks, such as fish oil supplements, bile-acid sequestrants, plant sterol
             supplements, fibrates, statins or Niacin.

          -  Subjects with hemoglobin <10g/dL

          -  Subject with platelet counts <60x103/microliter

          -  Subjects with uncontrolled hypertension (resting blood pressure > 160 mmHg systolic
             and /or > 100 mm Hg diastolic)

          -  Subject with uncontrolled diabetes (hemoglobin A1c (HbA1c) greater than or equal to
             10)

          -  Subjects who consume excessive alcohol (binge drinking on 5 or more days in the past
             month)

          -  Subject participating in other clinical studies and/or receiving other investigational
             drug products prior to randomization

          -  Subject taking PCSK9 inhibitors within 8 weeks prior to enrollment

          -  Subjects being treated with tamoxifen, estrogens, or progestins that have not been
             stable for >4 weeks.

          -  Subjects initiating new medications or patients on multiple medications may also be
             excluded according to investigator discretion

          -  Anticipated surgery during the study period

          -  Blood donation in the last 2 weeks or planned blood donation during the study

          -  Subjects requiring regular transfusions for any reason

          -  Subjects may also be excluded for any reason that may compromise their safety or the
             accuracy of research data.