Skip to main content
OpenTrials
Completed

NCT Number: NCT01091714

Is Omega-3 Fatty Acid Red Blood Cell (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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3

Dietary Supplement

Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.

Primary outcomes

  1. RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.

    Time frame: one month

Secondary outcomes

  1. RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Bucci Laser Vision Institute

Other

Registry information

Official study title

Is Omega-3 Fatty Acid RBC Saturation Product Dependent?

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
Registry last updated
Oct 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.