Assessment of PCSO-524 Relative to a Comparator Product
This study has been completed.
Sponsor:
Nutrasource Diagnostics Inc.
Collaborator:
Pharmalink International Ltd.
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT01564160
First received: March 22, 2012
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Dietary Supplement: Fish Oil Dietary Supplement: PCSO-524 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product. |
Resource links provided by NLM:
Further study details as provided by Nutrasource Diagnostics Inc.:
Primary Outcome Measures:
- Serum Phospholipid [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total Serum Lipid [ Time Frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose ] [ Designated as safety issue: No ]
- Serum Free Fatty Acid [ Time Frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1: PCSO-524
PCSO-524
|
Dietary Supplement: PCSO-524
Extract of Greenshell Mussel
|
|
Active Comparator: Arm 2: Fish Oil
Fish Oil
|
Dietary Supplement: Fish Oil
Source of omega-3 fatty acids.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564160
Locations
| Canada, Ontario | |
| Nutrasource Diagnostics Inc | |
| Guelph, Ontario, Canada, N1G0B4 | |
Sponsors and Collaborators
Nutrasource Diagnostics Inc.
Pharmalink International Ltd.
Investigators
| Principal Investigator: | Maggie D Laidlaw, Ph.D | Nutrasource Diagnostics |
More Information
Additional Information:
Web Recruitment 
No publications provided
| Responsible Party: | Nutrasource Diagnostics Inc. |
| ClinicalTrials.gov Identifier: | NCT01564160 History of Changes |
| Other Study ID Numbers: | 11.0202, 176412, 12-02-003 |
| Study First Received: | March 22, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Nutrasource Diagnostics Inc.:
|
Fish Oil EPA DHA Omega-Score |
Omega-3 Fatty Acids Green-Lipped Mussel Omega-score < 5.2% |
Additional relevant MeSH terms:
|
Alliin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013