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

Not Applicable

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: FishOil; Dietary Supplement: CBE75; Dietary Supplement: placebo; Dietary Supplement: CBE150

• Registration Number: NCT01671254
• Lead Sponsor: MetaProteomics LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FishOil + placebo	FishOil	Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
FishOil + CBE75	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	Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
FishOil + placebo	placebo	Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
FishOil + CBE150	FishOil	Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
FishOil + CBE150	CBE150	Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	Baseline, 8 weeks	Change in LDL cholesterol level at the end of 8 weeks

Secondary Outcome Measures

Name	Time	Method
Triglyceride	Baseline, 8 weeks	Change in triglyceride level at the end of 8 weeks.
oxLDL	Baseline, 8 weeks	Change in oxidized LDL level at the end of 8 weeks.
Total cholesterol	Baseline, 8 weeks	Change in total cholesterol level at the end of 8 weeks.
HDL cholesterol	Baseline, 8 weeks	Change in HDL cholesterol level at the end of 8 weeks.

Trial Locations

Locations (1)

Functional Medicine Research Center; 🇺🇸 Gig Harbor, Washington, United States