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

NCT02628483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-14

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • Nordic Pharma, USA

    lead INDUSTRY

Principal Investigators

  • Anthony Bier, MD · Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02628483 on ClinicalTrials.gov