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

Phase 4

Completed

• Conditions: Cardioprotective Levels
• Interventions: Dietary Supplement: Omega-3

• Registration Number: NCT01091714
• Lead Sponsor: Bucci Laser Vision Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Study Start: 2010-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRN Dry Eye Omega Benefits	Omega-3	4 capsules per day = 2240 mg Omega-3s
Nature's Made	Omega-3	2 capsules per day = 2400mg Omega-3s
Thera Tears	Omega-3	4 capsules per day = 2332mg Omega-3s

Primary Outcome Measures

Name	Time	Method
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.	one month

Secondary Outcome Measures

Name	Time	Method
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.	3 months

Trial Locations

Locations (1)

Bucci Laser Vision Institute; 🇺🇸 Wilkes-Barre, Pennsylvania, United States