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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671254
• Other study ID #: POT2-FMR-CT
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2018
• Source: MetaProteomics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• FishOil

• CBE75

• CBE150

• placebo

Locations

Country	Name	City	State
United States	Functional Medicine Research Center	Gig Harbor	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MetaProteomics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	Change in LDL cholesterol level at the end of 8 weeks	Baseline, 8 weeks
Secondary	Triglyceride	Change in triglyceride level at the end of 8 weeks.	Baseline, 8 weeks
Secondary	oxLDL	Change in oxidized LDL level at the end of 8 weeks.	Baseline, 8 weeks
Secondary	Total cholesterol	Change in total cholesterol level at the end of 8 weeks.	Baseline, 8 weeks
Secondary	HDL cholesterol	Change in HDL cholesterol level at the end of 8 weeks.	Baseline, 8 weeks