Sponsor study identifier
Secondary identifiers
interventional
200
1 country
1
Study Start
November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2026
Actual (reported)October 20, 2026
Actual (reported)November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and after each 8-week intervention period
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.
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.
Fish oil enriched in very-long-chain polyunsaturated fatty acids (VLCPUFAs), developed by Epax Norway AS.
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.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Marcelo J Amar, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
First Submitted
October 17, 2026
First Posted
October 20, 2026
Study Start
November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 1, 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10-14
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