Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?

Study Overview
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Brief Summary
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To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study.

Detailed Description
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To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. The HS-Omega-3 Index is a new test that measures blood levels of the cardioprotective omega-3 fatty acids, EPA and DHA. RBS saturation is being measured to identify how much Omega 3 is in the blood.

Official Title
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Is Omega-3 Fatty Acid RBC Saturation Product Dependent?

Conditions
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Cardioprotective Levels

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Omega-3
* Dietary Supplement: Omega-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give written informed consent. Subject motivation and willingness to cooperate with the investigator by following the required medication regimen. Subject willingness and ability to return for all visits during the study. Must be willing to discontinue all use of Omega-3 supplementation 2 weeks prior to study participation. Exclusion Criteria: Concurrent involvement in any other clinical trial involving an investigational drug or device. Compromised cognitive ability which may be expected to interfere with study compliance. Uncontrolled or poorly controlled systemic disease ot the presence of any significant illness that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study. Subjects must not eat more that 1 non-fried fish meal per week. Subjects must not have undergone any bariatric surgery or have a malabsorption disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRN Dry Eye Omega Benefits<br>4 capsules per day = 2240 mg Omega-3s | Dietary Supplement: Omega-3<br>* Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.<br>|
| Active Comparator: Nature's Made<br>2 capsules per day = 2400mg Omega-3s | Dietary Supplement: Omega-3<br>* Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.<br>|
| Active Comparator: Thera Tears<br>4 capsules per day = 2332mg Omega-3s | Dietary Supplement: Omega-3<br>* Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. |  | 3 months |