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

Completed · Phase 2

Conditions studied: Lipoprotein Metabolism, PCSK9, Proteomics

In brief

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.

Key facts

Study ID

NCT03043365

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

37

Starts

2017-06-15

Expected to finish

2019-11-21

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.