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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.
March 22, 2012
March 27, 2012
December 3, 2012
April 2012
August 2012   (Final data collection date for primary outcome measure)
Serum Phospholipid [ Time Frame: Day 0 and Day 21 ]
Same as current
Complete list of historical versions of study NCT01564160 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of PCSO-524 Relative to a Comparator Product
Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction 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.

Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Healthy
  • Dietary Supplement: Fish Oil
    Source of omega-3 fatty acids.
  • Dietary Supplement: PCSO-524
    Extract of Greenshell Mussel
  • Experimental: Arm 1: PCSO-524
    PCSO-524
    Intervention: Dietary Supplement: PCSO-524
  • Active Comparator: Arm 2: Fish Oil
    Fish Oil
    Intervention: Dietary Supplement: Fish Oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01564160
11.0202
176412 ( Other Identifier: Health Canada )
12-02-003 ( Other Identifier: Canadian SHIELD Ethics Review Board )
No
Not Provided
Not Provided
Nutrasource Diagnostics Inc.
Nutrasource Diagnostics Inc.
Pharmalink International Ltd.
Principal Investigator: Maggie D Laidlaw, Ph.D Nutrasource Diagnostics
Nutrasource Diagnostics Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP