Assessment of PCSO-524 Relative to a Comparator Product

NCT01564160 | Completed Early Phase 1

• 3 other identifiers: 11.020217641212-02-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Serum Phospholipid

  Day 0 and Day 21

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm 1: PCSO-524

EXPERIMENTAL

PCSO-524

Dietary Supplement: PCSO-524

Arm 2: Fish Oil

ACTIVE COMPARATOR

Fish Oil

Dietary Supplement: Fish Oil

Interventions

Fish Oil DIETARY_SUPPLEMENT

Source of omega-3 fatty acids.

Arm 2: Fish Oil

PCSO-524 DIETARY_SUPPLEMENT

Extract of Greenshell Mussel

Arm 1: PCSO-524

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: lead
• Pharmalink International Ltd.: collaborator

Study Sites (1)

Nutrasource Diagnostics Inc

Guelph, Ontario, N1G0B4, Canada

Location

MeSH Terms

Interventions

Fish Oils; PCSO-524

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Maggie D Laidlaw, Ph.D

  Nutrasource Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

CA (1)