VLCPUFA-rich fish oil and standard DHA oil: who reaches a higher omega-3 index?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind crossover trial compares VLCPUFA-enriched fish oil with a standard DHA-rich oil to see how each affects the omega-3 index in healthy adults. Participants will undergo multiple visits over roughly 28 to 30 weeks, including screening, supplementation periods, and follow-up. Primary outcome is the omega-3 index; secondary outcomes include biomarkers of lipoprotein metabolism and exploratory measures of cardiometabolic health, neurocognition, and visual function. The study is conducted at the NIH Clinical Center with NHLBI oversight and involves VLCPUFA-rich and DHA-rich oil as interventions.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Marcelo J Amar, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Joy Lynne V Freeman
• Email: joylynne.freeman@nih.gov
• Phone: (301) 480-7632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.