Clinical trial NCT01564160: Assessment of PCSO-524 Relative to a Comparator Product
Official title: Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Fish Oil
EPA
DHA
Omega-Score
Omega-3 Fatty Acids
Green-Lipped Mussel
Omega-score < 5.2%
Lead sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Sponsor class: NETWORK
Collaborators: name: Pharmalink International Ltd.
First posted: 2012-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility 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

Primary outcomes:
measure: Serum Phospholipid
timeFrame: Day 0 and Day 21
Secondary outcomes:
measure: Total Serum Lipid
timeFrame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
measure: Serum Free Fatty Acid
timeFrame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc
state: Ontario
Study officials:
affiliation: Nutrasource Diagnostics
name: Maggie D Laidlaw, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: