Assessment of PCSO-524 Relative to a Comparator Product

Nutrasource

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: PCSO-524; Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01564160

11.0202

12-02-003 (Other Identifier)

176412 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Arm 1: PCSO-524

Experimental group

Description:

PCSO-524

Treatment:

Dietary Supplement: PCSO-524

Arm 2: Fish Oil

Active Comparator group

Description:

Fish Oil

Treatment:

Dietary Supplement: Fish Oil