Phase 2
N=37
Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Lipoprotein Metabolism · PCSK9 · Proteomics
Bottom Line
View on ClinicalTrials.gov: NCT03043365 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Changes From Baseline in Lipid Profile at 8 Weeks — 52; 56.1; 184.3; 181.7 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- control fish oil (Drug); LCMUFA-rich saury oil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Lipid Profile at 8 Weeks |
52; 56.1; 184.3; 181.7; 67.9; 68.7 | — |
| SECONDARY Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB) |
29.7; 29; 14.4; 14.7; 6.3; 6.5 | — |
| SECONDARY Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL) |
75.3; 72.9 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03043365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.