Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Assessment of PCSO-524 Relative to a Comparator Product

This study has been completed.
Pharmalink International Ltd.
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc. Identifier:
First received: March 22, 2012
Last updated: November 30, 2012
Last verified: November 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 Intervention Phase
Dietary Supplement: Fish Oil
Dietary Supplement: PCSO-524
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Official Title: Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.

Resource links provided by NLM:

Further study details as provided by Nutrasource Diagnostics Inc.:

Primary Outcome Measures:
  • Serum Phospholipid [ Time Frame: Day 0 and Day 21 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: PCSO-524
Dietary Supplement: PCSO-524
Extract of Greenshell Mussel
Active Comparator: Arm 2: Fish Oil
Fish Oil
Dietary Supplement: Fish Oil
Source of omega-3 fatty acids.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01564160

Canada, Ontario
Nutrasource Diagnostics Inc
Guelph, Ontario, Canada, N1G0B4
Sponsors and Collaborators
Nutrasource Diagnostics Inc.
Pharmalink International Ltd.
Principal Investigator: Maggie D Laidlaw, Ph.D Nutrasource Diagnostics
  More Information

Additional Information:
Responsible Party: Nutrasource Diagnostics Inc. Identifier: NCT01564160     History of Changes
Other Study ID Numbers: 11.0202
176412 ( Other Identifier: Health Canada )
12-02-003 ( Other Identifier: Canadian SHIELD Ethics Review Board )
Study First Received: March 22, 2012
Last Updated: November 30, 2012

Keywords provided by Nutrasource Diagnostics Inc.:
Fish Oil
Omega-3 Fatty Acids
Green-Lipped Mussel
Omega-score < 5.2% processed this record on May 22, 2017