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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: PCSO-524; Dietary supplement: Fish Oil

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G0B4
      • Nutrasource Diagnostics Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Phospholipid	Day 0 and Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Serum Lipid	Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Serum Free Fatty Acid	Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

Collaborators and Investigators

• Sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Collaborators: Pharmalink International Ltd.
• Investigators: Principal Investigator: Maggie D Laidlaw, Ph.D, Nutrasource Diagnostics

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (ESTIMATE): March 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: DHA; Fish Oil; Omega-3 Fatty Acids; EPA; Omega-Score; Green-Lipped Mussel; Omega-score < 5.2%
• Other Study ID Numbers: 11.0202; 176412 (OTHER: Health Canada); 12-02-003 (OTHER: Canadian SHIELD Ethics Review Board)