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

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ClinicalTrials.gov Identifier: NCT03043365
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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 it s 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.


Condition or disease Intervention/treatment Phase
Lipoprotein Metabolism PCSK9 Proteomics Drug: control fish oil Drug: LCMUFA-rich saury oil Phase 2

Detailed Description:

Serum cholesterol is transported by lipoproteins, such as VLDL, LDL and HDL, which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty acids over 18 carbons in length with a single double bond, have been shown in mice to decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study will test the hypothesis that LCMUFA supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be affected by supplementation with omega-3 fatty acids.

This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Group 1
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 cross-over to the LCMUFA-rich saury oil capsule arm
Drug: control fish oil
4 capsules, 3 times a day after meals

Experimental: Group 2
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 crossoverto the control fish oil capsule arm
Drug: LCMUFA-rich saury oil
4 capsules, 3 times a day after meals




Primary Outcome Measures :
  1. Changes in the lipid profile (TC, TG, HDL-C and LDL-C) [ Time Frame: 24 weeks ]
    The primary outcome measures of this study will be changes differences between randomized groups in differences between treatment periods in changes from baseline to end of period in the plasma total cholesterol. between the control and research supplement group. Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size. Each subject will serve as their own control.


Secondary Outcome Measures :
  1. changes lipoprotein particle number, composition and size [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 EPA/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 (AST or ALT) levels above 3x upper limit of normal
  • Subjects with a TSH greater than 1.5xULN 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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043365


Contacts
Contact: OPR Office of Patient Recruitment (800) 411-1222 prpl@cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Marcelo J Amar, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03043365     History of Changes
Other Study ID Numbers: 170050
17-H-0050
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Fish Oils
Long Chain Monounsaturated Fatty Acids
Lipoproteins
Cardiovascular Disease