ClinicalTrials.gg
Sign In
RecruitingNCT07882160Updated Oct 23, 2026

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

An interventional study of VLCPUFA-rich fish oil and DHA-rich fish oil in Fatty Acids, Omega-3 and Fish Oils, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Basic science

Updated Oct 23, 2026Start date movedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

Study Description:

This study is designed to investigate changes in the omega-3 index (ratio of omega-3 fatty acids (eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)) over total RBC fatty acids) following supplementation with a fish oil enriched in very long chain polyunsaturated fatty acids (VLCPUFA) versus a standard, commercially available, over-the-counter (OTC), fish oil enriched in DHA. VLCPUFA-enriched fish oil provides roughly 10-fold the amount of VLCPUFA found in conventional fish oils. The oil was developed as a dietary supplement by Epax Norway AS. It may offer several potential advantages over standard fish oils in the improvement of risk factors for age-related macular degeneration (AMD) and cardiovascular disease (CVD) because of its higher content of VLCPUFAs. The study is designed as a double-blinded, randomized crossover study measuring differences in the omega-3 index following fish oil supplementation in healthy subjects.

Objectives:

Primary Objective: Compare the Omega-3 index score of participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.

Secondary Objective: Evaluate changes of biomarkers related to lipoprotein metabolism for VLCPUFA-rich fish oil.

Exploratory Objective:

  • Evaluate changes in clinical markers of cardiometabolic health, neurocognition and visual acuity with the VLCPUFA-rich fish oil.
  • Characterize the early absorption profile and interindividual variability of VLCPUFA-rich fish oil under standardized fasting conditions following a single oral dose in participants who elect to complete the optional overnight Metabolic Unit visit.

Endpoints:

Primary Endpoint: Changes in patient Omega-3 index in participants given DHA-rich fish oil (control) versus those given VLCPUFA-rich fish oil.

Secondary Endpoint: Changes in standard lipid panel and Nuclear Magnetic Resonance (NMR) lipoprotein profile in participants given DHA-rich fish oil versus those given VLCPUFA-rich fish oil.

Exploratory Endpoints:

  • Changes from baseline markers of glucose, fatty acid (FA) metabolism, red blood cell fatty acid profile, inflammation and coagulation in participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
  • Evaluate changes in neurocognitive tests and visual acuity tests from baseline in participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
  • Baseline-adjusted changes in plasma fatty acid concentrations (including VLCPUFAs and related omega-3 fatty acids) over the first approximately 2 hours following administration of the study product during the optional overnight Metabolic Unit visit.
02

Conditions studied

  • Fatty Acids, Omega-3
  • Fish Oils

Keywords

  • Omega-3 Index
  • Fish Oil
  • VLCPUFA
  • DHA
  • EPA
  • Omega-3 Fatty Acids
  • Lipoprotein Metabolism
03

In context

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.

Browse National Heart, Lung, and Blood Institute (NHLBI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

  1. Male or female, age 18-60 years, in good general health in accordance with PI evaluation.
  2. Body Mass Index (BMI) >18 and \<30 kg/m\^2.
  3. Ability to take oral medication.
  4. Participant demonstrates willingness to sign the informed consent form, comply with all study procedures.

  5. 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
  6. Screening labs within normal levels. Minor deviations from the normal screening labs are allowed per PI discretion.

Exclusion criteria

EXCLUSION CRITERIA

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

  1. 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).
  2. Subjects who have started or stopped medications that did not reach a stable baseline; subjects taking chronic medications or supplements.
  3. Pregnancy (or planned pregnancy) or lactation.
  4. Subjects planning a significant change in diet or exercise levels.
  5. Known allergic reactions to fish or shellfish or omega-3 fatty acids supplements, and subjects with bleeding disorders.
  6. Current use of anticoagulant or antiplatelet drugs.
  7. 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.
  8. Acute and life-threatening conditions, such as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism.
  9. Subject with known history of Atrial Fibrillation.
  10. Anticipated surgery during the study period.
  11. Previous blood donation within 3 months of the start of the study.
  12. Any other reason or clinical condition that the PI judges would interfere with study participation and/or be unsafe for a participant.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    DHA-rich Fish Oil VLCPUFA-rich Fish Oil

    Participants receive DHA-rich fish oil during the first intervention period, followed by VLCPUFA-rich fish oil during the second intervention period, according to the study crossover design.

    Dietary Supplement: VLCPUFA-rich fish oil · Dietary Supplement: DHA-rich fish oil

  • Experimental
    VLCPUFA-rich Fish Oil DHA-rich Fish Oil

    Participants receive VLCPUFA-rich fish oil during the first intervention period, followed by DHA-rich fish oil during the second intervention period, according to the study crossover design.

    Dietary Supplement: VLCPUFA-rich fish oil · Dietary Supplement: DHA-rich fish oil

Interventions

  • Dietary supplementVLCPUFA-rich fish oil

    Fish oil enriched in very-long-chain polyunsaturated fatty acids (VLCPUFAs), developed by Epax Norway AS.

  • Dietary supplementDHA-rich fish oil

    Standard commercially available over-the-counter fish oil enriched in docosahexaenoic acid (DHA), used as the comparator. In this randomized crossover study, participants receive both the DHA-rich fish oil and the VLCPUFA-rich fish oil in a randomized sequence.

06

What researchers measure

Primary outcomes

  1. Change in Omega-3 Index

    Change in the Omega-3 Index, defined as the percentage of EPA plus DHA relative to total red blood cell fatty acids, following supplementation with VLCPUFA-rich fish oil compared with control fish oil.

    Time frame: Baseline and after each 8-week intervention period

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contact · ccopr@nih.gov · 800-411-1222
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol

Time frame: 3-6 months after the publication

Access criteria: Data for this study will be shared in open access repositories

09

Timeline

4 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2026
First posted
Oct 20, 2026
StartEst.
Oct 28, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 25, 2026→Oct 28, 2026
moved 3 times, Oct 21, 2026 – Oct 23, 2026
Registered
First appeared on the registry
Oct 20, 2026
Show all 4 updates
  1. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  2. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  3. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  4. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882160
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Oct 28, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Joy Lynne V Freeman
Contact
joylynne.freeman@nih.gov
(301) 480-7632
Marcelo J Amar, M.D.
Contact
mamar@mail.nih.gov
(301) 402-0521
Marcelo J Amar, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

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

Start the discussion