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Completed

NCT Number: NCT01564160

Assessment of 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Nutrasource Diagnostics Inc

Guelph, Ontario, N1G0B4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Source of omega-3 fatty acids.

PCSO-524

Dietary Supplement

Extract of Greenshell Mussel

Primary outcomes

  1. Serum Phospholipid

    Time frame: Day 0 and Day 21

Secondary outcomes

  1. Total Serum Lipid

    Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

  2. Serum Free Fatty Acid

    Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

Sponsors and collaborators

Lead sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Network

Collaborators

  • Pharmalink International Ltd.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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