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

NCT02514070 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 15017315-H-0173
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LDL-C; Omega-3 Fatty Acid; PCSK9; HDL-C

Outcome Measures

Primary Outcomes (1)

• Plasma PCSK9 Levels at Baseline and End of 6 Week Intervention

  Measure plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) level, at baseline, after 6 weeks of Eicosapentaenoic acid (EPA) or Docosahexaenoic acid (DHA) fish oil supplementation.

  baseline to 6 weeks of intervention

Secondary Outcomes (1)

• Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks

  Baseline to 6 weeks of intervention

Study Arms (2)

EPA-rich fish oil arm then DHA-rich fish oil arm

EXPERIMENTAL

Subjects randomized to the EPA-rich fish oil arm will take the equivalent to 3g of EPA /day (12 gel capsules/day) for 6 more or less 1 weeks and cross-over to the DHA-rich capsule arm

Drug: EPA-rich fish oil

DHA-rich fish oil arm then EPA-rich fish oil arm

EXPERIMENTAL

Subjects randomized to the DHA-rich fish oil arm will take the equivalent to 3g of DHA /day (12 gel capsules/day) for 6 more or less 1 weeks and cross-over to the EPA-rich capsule arm

Drug: DHA-rich fish oil

Interventions

EPA-rich fish oil DRUG

4 gel capsules, 3 times/day for 6 weeks

Also known as: Eicosapentaenoic acid (EPA) Fish Oil

EPA-rich fish oil arm then DHA-rich fish oil arm

DHA-rich fish oil DRUG

4 gel capsules, 3 times/day for 6 weeks

Also known as: Docosahexaenoic acid (DHA) Fish Oil

DHA-rich fish oil arm then EPA-rich fish oil arm

Eligibility Criteria

• Age: 18 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.
• 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.
• Subjects taking supplements or medications that affect lipoproteins for at least the past six weeks including fish oil supplements, bile-acid sequestrants, plant sterol supplements, fibrates, statins or Niacin.
• Subjects diagnosed with cancer or IBD, or that have taken diarrhea inhibitors, laxatives or prebiotics in the week before stool sampling (optional), or antibiotics within 3 months before sampling.
• Subjects taking daily aspirin or other anti-platelet or anti-coagulants agents (Plavix).
• History of prostate Cancer
• Subjects with known bleeding disorders (for example, Hemophilia)
• Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements
• 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 transaminase (ALT)) levels above 3x upper limit of normal
• Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion
• Subjects previously diagnosed with cardiac dysrhythmia

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Eicosapentaenoic Acid; Fish Oils; Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

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

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: July 31, 2015
• First Posted: August 3, 2015
• Study Start: October 30, 2015
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: July 15, 2021
• Results First Posted: December 3, 2020

Record last verified: 2019-07-24

Locations

US (1)