Assessment of PCSO-524 Relative to a Comparator Product
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|ClinicalTrials.gov Identifier: NCT01564160|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : December 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Fish Oil Dietary Supplement: PCSO-524||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Arm 1: PCSO-524
Dietary Supplement: PCSO-524
Extract of Greenshell Mussel
Active Comparator: Arm 2: Fish Oil
Dietary Supplement: Fish Oil
Source of omega-3 fatty acids.
- Serum Phospholipid [ Time Frame: Day 0 and Day 21 ]
- Total Serum Lipid [ Time Frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose ]
- Serum Free Fatty Acid [ Time Frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564160
|Nutrasource Diagnostics Inc|
|Guelph, Ontario, Canada, N1G0B4|
|Principal Investigator:||Maggie D Laidlaw, Ph.D||Nutrasource Diagnostics|