Cardioprotective Levels
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOmega-3
Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
Sponsors
Bucci Laser Vision Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. | one month |
Secondary
| Measure | Time frame |
|---|---|
| RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. | 3 months |
Countries
United States
Outcome results
None listed