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

NCT01960660 | Completed

• 2 other identifiers: 12.021612-03-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Comparative Bioavailability

Keywords

Fish Oil; EPA; DHA; Omega-Score; Lipemic Index; ethyl esters; triglycerides; phospholipids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Lipemic IndexTM

  Change from Baseline in Lipemic Index at 28 days

Study Arms (4)

Investigational Product

EXPERIMENTAL

Omega-3 fatty acids in the form of triglycerides

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 1

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 2

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3 Fatty Acids

Comparator Product 3

ACTIVE COMPARATOR

Omega-3 fatty acids from salmon oil.

Dietary Supplement: Omega-3 Fatty Acids

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

Also known as: EPA: Eicosapentaenoic acid (20:5(n-3)), DHA: Docosahexaenoic acid (22:6(n-3))

Comparator Product 1; Comparator Product 2; Comparator Product 3; Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Pharma, USA: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource Diagnostics Inc

Guelph, Ontario, N1G0B4, Canada

Location

Related Publications (1)

• Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99.

  PMID: 24952576 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Maggie D Laidlaw, Ph.D

  Nutrasource Diagnostics

  PRINCIPAL INVESTIGATOR

• Carla Cockerline, M.Sc

  Nutrasource Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

CA (1)