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RECRUITING

NCT07882160

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

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-11-08

Completion Date

2027-12-01

Last Updated

2026-11-03

Healthy Volunteers

Yes

Conditions

Fatty Acids, Omega-3 Fish Oils

Interventions

DIETARY_SUPPLEMENT

VLCPUFA-rich fish oil

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

DIETARY_SUPPLEMENT

DHA-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.

* 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 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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States