NCT02628483

A Comparator Trial on the Relative Efficacy of Two Triglyceride Forms of Fish Oil

A Randomized, Double-blind, Parallel Clinical Trial to Compare the Relative Efficacy of Two Triglyceride Forms of Fish Oil, Ultimate Omega®, and a Comparator Product, in Improving Red Blood Cell Fatty Acid Profiles in Healthy Adults (FORCE Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nordic Pharma, USA · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The health benefits of omega-3 fatty acids have been extensively examined in many published studies, and these benefits have been observed in patients with a diversity of conditions and diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis, thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline, periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to healthy individuals, in terms of preventative health benefits. The balance between omega-6 long chain fatty acids and their omega-3 counterparts is important in health maintenance. An omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014 study of the dietary habits of U.S. adults revealed that, in general, North Americans do not meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to be considered, in order to help this population meet their daily needs. Both the Academy of Nutrition and Dietetics and the American Heart Association suggest a prudent approach in recommending an increased intake of omega-3 fatty acids. Although both organisations recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also recognise that supplementation may also be required in order to meet target values, particularly in at-risk populations. Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA and DHA and are available in varying forms including ethyl ester and high triglyceride forms. Differences in product formulation have been shown to have varying health effects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish Oil	1000mg fish oil per capsule (325mg EPA + 225mg DHA)
DIETARY_SUPPLEMENT	Fish Oil	1000mg fish oil per capsule (300mg EPA + 200mg DHA)

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-12-11
• Last updated: 2016-12-14

Locations

1 site across 1 country: Canada