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

NCT ID: NCT01091714

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Cardioprotective Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PRN Dry Eye Omega Benefits

4 capsules per day = 2240 mg Omega-3s

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.

Nature's Made

2 capsules per day = 2400mg Omega-3s

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

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

Thera Tears

4 capsules per day = 2332mg Omega-3s

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.

Interventions

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Omega-3

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

Intervention Type DIETARY_SUPPLEMENT

Omega-3

Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.

Intervention Type DIETARY_SUPPLEMENT

Omega-3

Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bucci Laser Vision Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank A Bucci, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute

Locations

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Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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01-2010

Identifier Type: -

Identifier Source: org_study_id

NCT01173185

Identifier Type: -

Identifier Source: nct_alias