Assessment of PCSO-524 Relative to a Comparator Product
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.
|Healthy||Dietary Supplement: Fish Oil Dietary Supplement: PCSO-524||Early Phase 1|
|Study Design:||Allocation: Randomized
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.|
- 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 ]
|Study Start Date:||April 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564160
|Nutrasource Diagnostics Inc|
|Guelph, Ontario, Canada, N1G0B4|
|Principal Investigator:||Maggie D Laidlaw, Ph.D||Nutrasource Diagnostics|