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

Not Applicable

Completed

• Conditions: Comparative Bioavailability
• Interventions: Dietary Supplement: Omega-3 Fatty Acids

• Registration Number: NCT01960660
• Lead Sponsor: Nordic Pharma, USA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Comparator Product 3	Omega-3 Fatty Acids	Omega-3 fatty acids from salmon oil.
Investigational Product	Omega-3 Fatty Acids	Omega-3 fatty acids in the form of triglycerides
Comparator Product 1	Omega-3 Fatty Acids	Omega-3 fatty acids in the form of ethyl esters.
Comparator Product 2	Omega-3 Fatty Acids	Omega-3 fatty acids in the form of phospholipids from krill oil.

Primary Outcome Measures

Name	Time	Method
Omega-Score	Change from Baseline in Omega-Score at 28 days	The Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.

Secondary Outcome Measures

Name	Time	Method
Lipemic IndexTM	Change from Baseline in Lipemic Index at 28 days	The Lipemic Index™ is the post-prandial rise in TG levels over a 5-hour period, following the consumption drink containing a measured amount of fat, carbohydrate and protein.

Trial Locations

Locations (1)

Nutrasource Diagnostics Inc; 🇨🇦 Guelph, Ontario, Canada