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

NCT03043365 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 17005017-H-0050
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipoprotein Metabolism; PCSK9; Proteomics

Keywords

Fish Oils; Long Chain Monounsaturated Fatty Acids (LCMUFA); Lipoproteins; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline in Lipid Profile at 8 Weeks

  The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.

  baseline and 8 weeks

Secondary Outcomes (2)

• Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)

  baseline and 8 weeks

• Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)

  baseline and 8 weeks

Study Arms (3)

Arm 1: Control Fish Oil first, then Saury Oil

EXPERIMENTAL

Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm

Drug: control fish oil

Arm 2: Saury Oil first, then Control Fish Oil

EXPERIMENTAL

Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm

Drug: LCMUFA-rich saury oil

Washout Period

NO INTERVENTION

8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time.

Interventions

control fish oil DRUG

4 capsules, 3 times a day after meals

Also known as: DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils), fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,, PUFA, W3 fatty acids

Arm 1: Control Fish Oil first, then Saury Oil

LCMUFA-rich saury oil DRUG

4 capsules, 3 times a day after meals

Also known as: long-chain monounsaturated fatty acids

Arm 2: Saury Oil first, then Control Fish Oil

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Docosahexaenoic Acids; Eicosapentaenoic Acid; Fish Oils; Fatty Acids, Unsaturated

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids; Oils; Eicosanoids

Results Point of Contact

• Title: Marcelo J. Amar, M.D. Principal Investigator, NIH, NHLBI
• Organization: National Heart Lung and Blood Institute (NHLBI)

mamar@nhlbi.nih.gov

301-402-0521

Study Officials

• Marcelo J Amar, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 6, 2017
• Study Start: June 15, 2017
• Primary Completion: May 29, 2019
• Study Completion: November 21, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2019-11

Locations

US (1)