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

Is Omega-3 Fatty Acid RBC Saturation Product Dependent?

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.

Study Overview

• Status: Completed
• Conditions: Cardioprotective Levels
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Omega-3; Dietary supplement: Omega-3

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bucci Laser Vision Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (ESTIMATE): March 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 01-2010