Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
NCT ID: NCT01671254
Last Updated: 2018-05-18
Study Results
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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COMPLETED
NA
18 participants
INTERVENTIONAL
2012-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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FishOil + placebo
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
FishOil
placebo
FishOil + CBE75
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
FishOil
CBE75
FishOil + CBE150
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
FishOil
CBE150
Interventions
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FishOil
CBE75
CBE150
placebo
Eligibility Criteria
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Inclusion Criteria
* generally healthy
* BMI \> 18 and \< 38
* LDL cholesterol ≥ 130 mg/dl and \< 270 mg/dl
* triglycerides ≥ 150 mg/dl and \< 400 mg/dl
* ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
* use of omega-3 fatty acid dietary supplements within 30 days prior to the study
* use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin
* use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions
* history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness.
* known infection with HIB, TB, hepatitis B or hepatitis C
* history of allergy or intolerance to study products
* smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior to the study
* history of regular intake of \> 14 alcoholic drinks per week for females and \> 21 drinks per week for males
18 Years
72 Years
ALL
Yes
Sponsors
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MetaProteomics LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph J Lamb, MD
Role: PRINCIPAL_INVESTIGATOR
MetaProteomics / Metagenics / FMRC
Locations
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Functional Medicine Research Center
Gig Harbor, Washington, United States
Countries
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Other Identifiers
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POT2-FMR-CT
Identifier Type: -
Identifier Source: org_study_id
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