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

• Status: Completed
• Trial end date: 2019-11-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.