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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultimate Omega | Experimental | 5 capsules of Ultimate Omega fish oil daily in the morning with food |
|
| Meg-3 | Active Comparator | 5 capsules of Meg-3 fish oil daily in the morning with food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | 1000mg fish oil per capsule (325mg EPA + 225mg DHA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell EPA and DHA | 24 weeks | |
| Phospholipid EPA and DHA | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell EPA and DHA | 12 and 16 weeks | |
| Lipid profile | Total cholesterol, LDL-C, HDL-C and triglycerides | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Anthropometric Measurements | Blood pressure, Heart rate, Weight and BMI | 4, 12, 16 and 24 weeks |
| Safety blood parameters | Complete blood count, electrolytes, markers of kidney and liver function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bier, MD | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource | Guelph | Ontario | N1G 0B4 | Canada |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| Fish Oil | Dietary Supplement | 1000mg fish oil per capsule (300mg EPA + 200mg DHA) |
|
|
| 24 weeks |
| Adverse Events | Adverse events over the supplementation period | 24 weeks |