A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products

Nordic Pharma

Status: Completed

Conditions: Comparative Bioavailability

Treatments: Dietary Supplement: Omega-3 Fatty Acids

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01960660

12-03-001 (Other Identifier)

12.0216

Details and patient eligibility

About

Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.

The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is fluent in English
• Participant understands the study requirements and is willing to comply with the protocol
• Participant is willing to provide written informed consent
• Participant is 18 years of age or older

Exclusion criteria

• Unwilling or unable to provide written consent
• Participant has taken omega-3 supplements in the last 3 months
• Participants consumes fish on a regular basis (more than 1 serving per week)
• Females who are pregnant or breastfeeding
• Participant has an allergy to fish or seafood
• Participant has been diagnosed with any medical illness or conditions
• Participant has a history of drug dependence or substance abuse (excluding nicotine)
• Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)
• Individual has difficulty giving multiple blood samples

Trial design

35 participants in 4 patient groups

Investigational Product

Experimental group

Description:

Omega-3 fatty acids in the form of triglycerides

Treatment:

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 1

Active Comparator group

Description:

Omega-3 fatty acids in the form of ethyl esters.

Treatment:

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 2

Active Comparator group

Description:

Omega-3 fatty acids in the form of phospholipids from krill oil.

Treatment:

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 3

Active Comparator group

Description:

Omega-3 fatty acids from salmon oil.

Treatment:

Dietary Supplement: Omega-3 Fatty Acids