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Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals

National Heart, Lung, and Blood Institute (NHLBI) · NCT07882160

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
1
Study start
October 29, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Background

Fish oils contain omega-3 fatty acids that play important roles in the body. Researchers are studying a new type of fish oil that contains very-long-chain omega-3 fatty acids (VLCPUFAs). They want to learn how this fish oil affects omega-3 levels in the blood and other measures related to health.

Objective

To learn how a VLCPUFA-enriched fish oil changes omega-3 levels in the blood compared with a standard fish oil.

Eligibility

Healthy adults ages 18 to 60 years with a body mass index (BMI) between 18 and 30 kg/m\^2 may be eligible.

Design

Participants will take part in the study for about 28 to 30 weeks and will have approximately 4 to 5 clinic visits plus a follow-up phone call.

Participants will complete screening tests to determine whether they are eligible. These may include a physical examination, blood tests, measurement of height and weight, visual testing, cognitive testing, and questions about their diet, exercise, medications, and daily habits.

Participants will take 2 fish oil capsules by mouth every day for 8 weeks. They will then stop taking study capsules for about 12 weeks. After that, they will take a different fish oil capsule for another 8 weeks.

One fish oil contains very-long-chain omega-3 fatty acids (VLCPUFAs), and the other contains standard omega-3 fatty acids. Participants will not know which type they are taking during each study period.

Blood samples and other study assessments will be collected at the beginning and end of each treatment period to measure changes in omega-3 levels and other study markers.

Participants will receive a follow-up phone call about one week after taking their last dose of study supplement.

Being studied: VLCPUFA-rich fish oil; DHA-rich fish oil

Conditions: Fatty Acids, Omega-3; Fish Oils

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all the following criteria:

  • Male or female, age 18-60 years, in good general health in accordance with PI evaluation.
  • Body Mass Index (BMI) >18 and \<30 kg/m\^2.
  • Ability to take oral medication.
  • Participant demonstrates willingness to sign the informed consent form, comply with all study procedures.
  • For females of childbearing potential, stated willingness to use an accepted method of contraception for the duration of the study. Accepted methods of contraception are:
  • Contraceptive implant
  • Intrauterine device (hormonal or copper IUD)
  • Permanent procedures: vasectomy, bilateral salpingectomy, or tubal occlusion
  • Oral contraceptives (the pill)
  • Contraceptive patch
  • Contraceptive vaginal ring
  • Injectable contraceptives
  • Male or female condoms (typically as a secondary method)
  • Diaphragm or cervical cap
  • Sterilization (of either partner)
  • Previously documented menopause for women as applicable
  • Screening labs within normal levels. Minor deviations from the normal screening labs are allowed per PI discretion.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Current or recent (2 months or less) use of omega-3 fatty acid supplements or foods enriched with omega-3 fatty acids (no more than two servings of fish per week), bile-acid sequestrants, plant sterol supplements, anticoagulants, fibrates, Niacin, or daily use of NSAIDs or medication that can affect lipid metabolism or any endpoint of the study (to be reviewed by the PI).
  • Subjects who have started or stopped medications that did not reach a stable baseline; subjects taking chronic medications or supplements.
  • Pregnancy (or planned pregnancy) or lactation.
  • Subjects planning a significant change in diet or exercise levels.
  • Known allergic reactions to fish or shellfish or omega-3 fatty acids supplements, and subjects with bleeding disorders.
  • Current use of anticoagulant or antiplatelet drugs.
  • History of heavy menstruation, chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or presence of other conditions that could affect intestinal fat absorption.
  • Acute and life-threatening conditions, such as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism.
  • Subject with known history of Atrial Fibrillation.
  • Anticipated surgery during the study period.
  • Previous blood donation within 3 months of the start of the study.
  • Any other reason or clinical condition that the PI judges would interfere with study participation and/or be unsafe for a participant.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: NIH Clinical Center Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Joy Lynne V Freeman · (301) 480-7632 · joylynne.freeman@nih.gov
  • Marcelo J Amar, M.D. · (301) 402-0521 · mamar@mail.nih.gov
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