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

NCT03043365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-08-12

Study results available
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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

Interventions

DRUG

control fish oil

4 capsules, 3 times a day after meals

DRUG

LCMUFA-rich saury oil

4 capsules, 3 times a day after meals

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Marcelo J Amar, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2019-05-29
Completion
2019-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043365 on ClinicalTrials.gov