HealthyEarly Phase 1NCT01564160
Assessment of PCSO-524 Relative to a Comparator Product
A Early Phase 1 study testing Fish Oil and PCSO-524 in people with Healthy, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fish Oil and PCSO-524
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Aug 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction 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.
- Conditions
- Healthy
- Being tested
- Fish Oil, PCSO-524
- Keywords
- Fish Oil, EPA, DHA, Omega-Score, Omega-3 Fatty Acids, Green-Lipped Mussel, Omega-score < 5.2%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Source of omega-3 fatty acids.
PCSO-524Dietary supplement
Extract of Greenshell Mussel
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PCSO-524 | Experimental | PCSO-524 Receives: Dietary Supplement: PCSO-524 |
| Arm 2: Fish Oil | Active comparator | Fish Oil Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Phospholipid
Measured: Day 0 and Day 21
Secondary outcomes (2)
Total Serum Lipid
Measured: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Serum Free Fatty Acid
Measured: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Sponsor type
- Research network
- Collaborators
- Pharmalink International Ltd.
- Responsible party
- Sponsor
- Investigators
- Maggie D Laidlaw, Ph.D, Principal investigator, Nutrasource Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564160
- Sponsor's protocol ID
- 11.0202
- Other IDs
- 176412, 12-02-003
- Status last verified
- Nov 2012
- First submitted
- 22 Mar 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.
- ClinicalTrials.gov ID
- NCT01564160
- Acronym / sponsor ID
- 11.0202
- Conditions
- Healthy
- Keywords
- Fish Oil, EPA, DHA, Omega-Score, Omega-3 Fatty Acids, Green-Lipped Mussel, Omega-score < 5.2%
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Research network
- Collaborators
- Pharmalink International Ltd.
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PCSO-524 | Experimental | Dietary Supplement: PCSO-524PCSO-524 |
| Arm 2: Fish Oil | Active comparator | Dietary Supplement: Fish OilFish Oil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilSource of omega-3 fatty acids. | Dietary supplement | Arm 2: Fish Oil |
| PCSO-524Extract of Greenshell Mussel | Dietary supplement | Arm 1: PCSO-524 |
Primary outcome
Serum Phospholipid
Time frame: Day 0 and Day 21
2 secondary outcomes
Total Serum Lipid
Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Serum Free Fatty Acid
Time frame: Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie D Laidlaw, Ph.D principal investigator
Nutrasource Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fish Oil and PCSO-524 in people with Healthy, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Phospholipid (time frame: Day 0 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.