Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
Condition: Lipoprotein Metabolism; PCSK9; Proteomics
Intervention: EPA-rich fish oil; DHA-rich fish oil
Intervention description: 4 gel capsules, 3 times/day for 6 weeks; 4 gel capsules, 3 times/day for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LDL-C; Omega-3 Fatty Acid; PCSK9; HDL-C

Summary:

      Background:

      - Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are
      substances found in foods such as cold-water fish and shellfish that are essential for good
      health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and
      docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health.

      Objective:

      - To understand the effects of EPA and DHA on metabolism.

      Eligibility:

      - Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood)
      levels of 100 mg/dL or higher

      Design:

        -  The study will last 20 to 24 weeks.

        -  Participants will have 4 visits to the NIH Clinical Center. These will include:

        -  Medical history

        -  Physical Fasting blood and urine tests

        -  CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.

        -  Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3
           times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a
           wash-out period). They will then take the capsules again for 6 or 7 weeks.

        -  Participants will keep a food journal.
    

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.

          -  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.

          -  Subjects taking supplements or medications that affect lipoproteins for at least the
             past six weeks including fish oil supplements, bile-acid sequestrants, plant sterol
             supplements, fibrates, statins or Niacin.

          -  Subjects diagnosed with cancer or IBD, or that have taken diarrhea inhibitors,
             laxatives or prebiotics in the week before stool sampling (optional), or antibiotics
             within 3 months before sampling.

          -  Subjects taking daily aspirin or other anti-platelet or anti-coagulants agents
             (Plavix).

          -  History of prostate Cancer

          -  Subjects with known bleeding disorders (for example, Hemophilia)

          -  Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements

          -  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 transaminase (ALT)) levels
             above 3x upper limit of normal

          -  Subjects initiating new medications or patients on multiple medications may also be
             excluded according to investigator discretion

          -  Subjects previously diagnosed with cardiac dysrhythmia

          -  Subjects with clinically diagnosed hepatic disease (including but not limited to auto
             immune disease, hepatitis and cirrhosis)

          -  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.

          -  Subjects being treated with tamoxifen, estrogens, or progestins that have not been
             stable for >4 weeks.

          -  Subjects that thyroid stimulating hormone (TSH) levels are greater than 1.5 x Upper
             Limit of Normal (ULN) or clinical evidence of hypothyroidism