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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01091714
First received: March 18, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Cardioprotective Levels
Dietary Supplement: Omega-3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Is Omega-3 Fatty Acid RBC Saturation Product Dependent?

Resource links provided by NLM:


Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PRN Dry Eye Omega Benefits
4 capsules per day = 2240 mg Omega-3s
Dietary Supplement: Omega-3
Approximately 2240 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.
Active Comparator: Thera Tears
4 capsules per day = 2332mg Omega-3s
Dietary Supplement: Omega-3
Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091714

Locations
United States, Pennsylvania
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Bucci Laser Vision Institute
Investigators
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision Institute
  More Information

No publications provided

Responsible Party: Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01091714     History of Changes
Obsolete Identifiers: NCT01173185
Other Study ID Numbers: 01-2010
Study First Received: March 18, 2010
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014