Healthy
Conditions
Keywords
Fish Oil, EPA, DHA, Omega-Score, Omega-3 Fatty Acids, Green-Lipped Mussel, Omega-score < 5.2%
Brief summary
A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids. The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day) bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of healthy adult participants.
Interventions
DIETARY_SUPPLEMENTFish Oil
Source of omega-3 fatty acids.
DIETARY_SUPPLEMENTPCSO-524
Extract of Greenshell Mussel
Sponsors
Pharmalink International Ltd.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* The individual is fluent in English and understands the study requirements * The participant is willing and able to comply with all requirements defined within this protocol. * The individual is willing to provide written informed consent * The individual is male or female * The individual is between 18 and 65 years of age * The individual's blood EPA+DPA+DHA ≤ 5.2% at screening
Exclusion criteria
* The individual is unable to or refuses to provide written informed consent * The individual has taken omega-3 supplements within 3 months of screening. * Supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea * The individual's blood EPA+DPA+DHA ≥ 5.2% at screening * The individual is female and pregnant or breastfeeding, or plans to be during the trial period * The individual has known allergies product ingredients (fish/seafood) * The individual has any significant medical illness or condition * The individual has reported a history of drug dependence or substance abuse (excluding nicotine) * The individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.) * The individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit * The individual will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Phospholipid | Day 0 and Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Total Serum Lipid | Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose |
| Serum Free Fatty Acid | Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose |
Countries
Canada
Outcome results
None listed