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Assessment of PCSO-524 Relative to a Comparator Product

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564160
First Posted: March 27, 2012
Last Update Posted: December 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pharmalink International Ltd.
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
  Purpose

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
Healthy Dietary Supplement: Fish Oil Dietary Supplement: PCSO-524 Early Phase 1

Study Type: Interventional
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.

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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

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


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

Additional Information:
Responsible Party: Nutrasource Diagnostics Inc.
ClinicalTrials.gov 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 )
First Submitted: March 22, 2012
First Posted: March 27, 2012
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by Nutrasource Diagnostics Inc.:
Fish Oil
EPA
DHA
Omega-Score
Omega-3 Fatty Acids
Green-Lipped Mussel
Omega-score < 5.2%