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

• Triglyceride [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Change in triglyceride level at the end of 8 weeks.
• oxLDL [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Change in oxidized LDL level at the end of 8 weeks.
• Total cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Change in total cholesterol level at the end of 8 weeks.
• HDL cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Change in HDL cholesterol level at the end of 8 weeks.

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

• Dietary Supplement: FishOil
• Dietary Supplement: CBE75
• Dietary Supplement: CBE150
• Dietary Supplement: placebo

• Active Comparator: FishOil + placebo
  Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
  Interventions:

  • Dietary Supplement: FishOil
  • Dietary Supplement: placebo
• Experimental: FishOil + CBE75
  Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
  Interventions:

  • Dietary Supplement: FishOil
  • Dietary Supplement: CBE75
• Experimental: FishOil + CBE150
  Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
  Interventions:

  • Dietary Supplement: FishOil
  • Dietary Supplement: CBE150

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