Assessment of PCSO-524 Relative to a Comparator Product

Healthy Clinical Trial

Official title:

Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564160
• Other study ID #: 11.0202
• Secondary ID: 17641212-02-003
• Status: Completed
• Phase: Phase 0
• First received: March 22, 2012
• Last updated: November 30, 2012
• Start date: April 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Nutrasource Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Fish Oil
Source of omega-3 fatty acids.
• PCSO-524
Extract of Greenshell Mussel

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nutrasource Diagnostics Inc.	Pharmalink International Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Phospholipid		Day 0 and Day 21	No
Secondary	Total Serum Lipid		Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose	No
Secondary	Serum Free Fatty Acid		Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose	No

External Links

•   Web Recruitment