💬In plain words
What the trial is, and whether it could suit you
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,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* 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.
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