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CompletedNCT01564160Updated Dec 3, 2012

Assessment of PCSO-524 Relative to a Comparator Product

An Early Phase 1 interventional study of Fish Oil and PCSO-524 in Healthy, sponsored by Nutrasource Pharmaceutical and Nutraceutical Services, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-03.

Sponsored by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. · Early Phase 1 and Interventional

Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • Fish Oil
  • EPA
  • DHA
  • Omega-Score
  • Omega-3 Fatty Acids
  • Green-Lipped Mussel
  • Omega-score < 5.2%
03

In context

Lead sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Early Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Arm 1: PCSO-524

    PCSO-524

    Dietary Supplement: PCSO-524

  • Active comparator
    Arm 2: Fish Oil

    Fish Oil

    Dietary Supplement: Fish Oil

Interventions

  • Dietary supplementFish Oil

    Source of omega-3 fatty acids.

  • Dietary supplementPCSO-524

    Extract of Greenshell Mussel

06

What researchers measure

Primary outcomes

  1. Serum Phospholipid

    Time frame: Day 0 and Day 21

Secondary outcomes

  1. Total Serum Lipid

    Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

  2. Serum Free Fatty Acid

    Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

07

Study locations

1 site
  • Nutrasource Diagnostics Inc
    Guelph, Ontario N1G0B4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01564160
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborators
Pharmalink International Ltd.
Responsible party
Sponsor
First posted
Mar 27, 2012
Start date
Apr 2012
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Dec 3, 2012

Study contacts

Maggie D Laidlaw, Ph.D
principal investigator · Nutrasource Diagnostics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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