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

MetaProteomics LLC1 site in 1 country18 target enrollmentAugust 2012

ConditionsHyperlipidemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hyperlipidemia
Sponsor: MetaProteomics LLC
Enrollment: 18
Locations: 1
Primary Endpoint: LDL cholesterol
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

December 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MetaProteomics LLC

Responsible Party

Sponsor

Eligibility Criteria

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