A Phase 2 interventional study of Fish Oil and Fish Oil in Healthy Volunteers, sponsored by Nordic Pharma, USA. Completed at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-14.
Sponsored by Nordic Pharma, USA · Phase 2 and Interventional
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.
Nordic Pharma, USA is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 capsules of Ultimate Omega fish oil daily in the morning with food
Dietary Supplement: Fish Oil
5 capsules of Meg-3 fish oil daily in the morning with food
Dietary Supplement: Fish Oil
1000mg fish oil per capsule (325mg EPA + 225mg DHA)
Also known as: Ultimate Omega
1000mg fish oil per capsule (300mg EPA + 200mg DHA)
Also known as: Meg-3
Red blood cell EPA and DHA
Time frame: 24 weeks
Phospholipid EPA and DHA
Time frame: 4 weeks
Red blood cell EPA and DHA
Time frame: 12 and 16 weeks
Lipid profile
Total cholesterol, LDL-C, HDL-C and triglycerides
Time frame: 24 weeks
Safety Anthropometric Measurements
Blood pressure, Heart rate, Weight and BMI
Time frame: 4, 12, 16 and 24 weeks
Safety blood parameters
Complete blood count, electrolytes, markers of kidney and liver function
Time frame: 24 weeks
Adverse Events
Adverse events over the supplementation period
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Nordic Pharma, USA