Omega-3 status in healthy adults: comparing different fish-oil and algae-oil products
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Virtual Clinical Trial to Investigate the Efficacy of Marine Oil Products on Omega-3 Status in Healthy Adults
Run by Nordic Naturals · NCT07900425 · Data updated 2026-11-12
This study tests whether various fish-oil and algae-oil products can raise the Omega-3 Index in healthy adults who don’t eat much fatty fish.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Nordic Naturals Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London, Ontario) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | October 26, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07900425 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older who do not regularly eat fatty fish and are not planning pregnancy during the study period.
✕Probably not a fit
Individuals who already have high Omega-3 status or do not respond to supplementation may see little or no improvement.
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, placebo-controlled trial evaluates how different omega-3 supplement formats affect Omega-3 Index in healthy adults. Participants will use softgels, liquids, or gummies containing fish-oil or algae-oil products, while continuing their usual diet and lifestyle. The study uses a parallel design to compare multiple active products against controls and will measure changes in EPA and DHA levels in red blood cells over time. The aim is to see if these products can safely boost omega-3 status and potentially reduce cardiovascular risk markers. Enrollment focuses on adults 18 and older who are not regular fatty fish consumers.
Why it matters
Potential benefit: If successful, participants may experience an improvement in omega-3 status, which could be associated with lower cardiovascular risk markers.
How similar studies have gone: Previous research suggests algae and fish oil can raise Omega-3 levels, supporting potential benefit in similar approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
KGK Science Inc
London, Ontario, Canada Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.