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Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults

NCT02514070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-07-15

Study results available
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Summary

Background:

\- Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health.

Objective:

\- To understand the effects of EPA and DHA on metabolism.

Eligibility:

\- Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood) levels of 100 mg/dL or higher

Design:

* The study will last 20 to 24 weeks.
* Participants will have 4 visits to the NIH Clinical Center. These will include:
* Medical history
* Physical Fasting blood and urine tests
* CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.
* Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3 times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a wash-out period). They will then take the capsules again for 6 or 7 weeks.
* Participants will keep a food journal.

Conditions

  • Lipoprotein Metabolism
  • PCSK9
  • Proteomics

Interventions

DRUG

EPA-rich fish oil

4 gel capsules, 3 times/day for 6 weeks

DRUG

DHA-rich fish oil

4 gel capsules, 3 times/day for 6 weeks

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2019-07-23
Completion
2019-07-23
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 NCT02514070 on ClinicalTrials.gov