Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation

Study Overview
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Brief Summary
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The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects

Official Title
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A Double-blind, Placebo-controlled Trial of a Dietary Supplement Containing Citrus Bioflavonoids and Vitamin E at 2 Doses in Conjunction With Fish Oil Supplementation in Hyperlipidemic Subjects

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: FishOil
* Dietary Supplement: CBE75
* Dietary Supplement: CBE150
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women ≥ 18 and ≤ 72 years old 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 nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FishOil + placebo<br>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule | Dietary Supplement: FishOil<br> <br> Dietary Supplement: placebo<br> <br> |
| Experimental: FishOil + CBE75<br>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day) | Dietary Supplement: FishOil<br> <br> Dietary Supplement: CBE75<br> <br> |
| Experimental: FishOil + CBE150<br>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day) | Dietary Supplement: FishOil<br> <br> Dietary Supplement: CBE150<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol | Change in LDL cholesterol level at the end of 8 weeks | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride | Change in triglyceride level at the end of 8 weeks. | Baseline, 8 weeks | 
| oxLDL | Change in oxidized LDL level at the end of 8 weeks. | Baseline, 8 weeks | 
| Total cholesterol | Change in total cholesterol level at the end of 8 weeks. | Baseline, 8 weeks | 
| HDL cholesterol | Change in HDL cholesterol level at the end of 8 weeks. | Baseline, 8 weeks |