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OpenTrials
Completed

NCT Number: NCT01671254

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

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

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Functional Medicine Research Center

Gig Harbor, Washington, 98332, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FishOil

Dietary Supplement

CBE75

Dietary Supplement

CBE150

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. LDL cholesterol

    Time frame: Baseline, 8 weeks

    Change in LDL cholesterol level at the end of 8 weeks

Secondary outcomes

  1. Triglyceride

    Time frame: Baseline, 8 weeks

    Change in triglyceride level at the end of 8 weeks.

  2. oxLDL

    Time frame: Baseline, 8 weeks

    Change in oxidized LDL level at the end of 8 weeks.

  3. Total cholesterol

    Time frame: Baseline, 8 weeks

    Change in total cholesterol level at the end of 8 weeks.

  4. HDL cholesterol

    Time frame: Baseline, 8 weeks

    Change in HDL cholesterol level at the end of 8 weeks.

Sponsors and collaborators

Lead sponsor

MetaProteomics LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 23, 2012
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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