Assessment of PCSO-524 Relative to a Comparator Product

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: PCSO-524; Dietary Supplement: Fish Oil

• Registration Number: NCT01564160
• Lead Sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: PCSO-524	PCSO-524	PCSO-524
Arm 2: Fish Oil	Fish Oil	Fish Oil

Primary Outcome Measures

Name	Time	Method
Serum Phospholipid	Day 0 and Day 21

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nutrasource Diagnostics Inc; 🇨🇦 Guelph, Ontario, Canada