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

Comparative Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960660
• Other study ID #: 12.0216
• Secondary ID: 12-03-001
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: December 10, 2015
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: Nordic Pharma, USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Comparative Bioavailability

Intervention

Dietary Supplement:
• Omega-3 Fatty Acids

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Pharma, USA	Nutrasource Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-Score	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.	Change from Baseline in Omega-Score at 28 days	No
Secondary	Lipemic IndexTM	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.	Change from Baseline in Lipemic Index at 28 days	No