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

Bucci Laser Vision Institute

Status and phase: Completed; Phase 4

Conditions: Cardioprotective Levels

Treatments: Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT01091714

01-2010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

PRN Dry Eye Omega Benefits

Active Comparator group

Description:

4 capsules per day = 2240 mg Omega-3s

Treatment:

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3

Nature's Made

Active Comparator group

Description:

2 capsules per day = 2400mg Omega-3s

Treatment:

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3

Thera Tears

Active Comparator group

Description:

4 capsules per day = 2332mg Omega-3s

Treatment:

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3

Dietary Supplement: Omega-3