Assessment of PCSO-524 Relative to a Comparator Product

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: PCSO-524


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: PCSO-524<br>PCSO-524 | Dietary Supplement: PCSO-524<br>* Extract of Greenshell Mussel<br>|
| Active Comparator: Arm 2: Fish Oil<br>Fish Oil | Dietary Supplement: Fish Oil<br>* Source of omega-3 fatty acids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phospholipid |  | Day 0 and Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish Oil, EPA, DHA, Omega-Score, Omega-3 Fatty Acids, Green-Lipped Mussel, Omega-score < 5.2%