Inclusion Criteria
1. Males and females 18 years and older
2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Individuals of child-bearing potential must self-report that they are not pregnant and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study 3. Normal diet includes low fatty fish intake (≤4 servings per month) 4. Agrees to avoid consuming foods and beverages fortified with omega-3 fatty acids for the study duration 5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 6. Provided voluntary, written, informed consent to participate in the study 7. Willing and able to consume study product and complete all questionnaires, diaries, and assessments required for participation 8. Healthy as determined by medical history and no unstable diagnosed medical conditions 7.2 Exclusion Criteria
1. Individuals who self-report as being pregnant, breast feeding, or planning to become pregnant during the study
2. Self-reported allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
3. Self-reported allergy to marine foods and/or by-products (e.g, fish, shellfish, or seafood)
4. Self-reported current use of omega-3 supplements (see Section 7.3.2)
5. Self-reported ongoing and unstable diseases/conditions in the past six months, including:
1. Gastrointestinal diseases
2. Hypertension
3. Type I or type II diabetes
4. Cardiovascular disease
5. Kidney and/or liver diseases
6. Thyroid condition
7. Autoimmune disease or immune compromised
6. Self-reported confirmation of any significant psychological condition/disorders
7. Self-reported major surgery in the past 3 months or individuals who have planned surgery during the course of the study
8. Self-reported cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
9. Self-reported confirmation of blood/bleeding disorders
10. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
11. Self-reported alcohol intake average of >2 standard drinks per day
12. Self-reported alcohol or drug abuse within the last 12 months that has required treatment
13. Self-reported use of cannabinoid products of >2 times per week
14. Self-reported current use of prescribed and/or OTC medications/supplements that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
15. Participation in other clinical research studies 30 days prior to randomization
16. Individuals who are unable to give informed consent
17. Any other condition or lifestyle factor that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant 7.3 Concomitant Medications Participants who are taking any prescribed medications that are considered not to affect the study outcomes must agree to maintain their current dosing regimen during the study unless otherwise recommended by their general practitioner/nurse practitioner.
7.3.1 Prescribed Medications Not applicable. 7.3.2 Over-the-counter Medications, Supplements, and Food/Drinks Participants who are currently consuming the following OTC medications, supplement and food/drinks will not be allowed to participate..
1\. Omega-3 supplements