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

• 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.