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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01671254

Enrollment

Registered

2012-08-23

Start date

2012-08-31

Completion date

2012-12-31

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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

Interventions

DIETARY_SUPPLEMENTFishOil

DIETARY_SUPPLEMENTCBE75

DIETARY_SUPPLEMENTCBE150

DIETARY_SUPPLEMENTplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 72 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
LDL cholesterol	Baseline, 8 weeks	Change in LDL cholesterol level at the end of 8 weeks

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026