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

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ClinicalTrials.gov Identifier: NCT01671254
Recruitment Status : Unknown
Verified August 2012 by MetaProteomics LLC.
Recruitment status was:  Recruiting
First Posted : August 23, 2012
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Hyperlipidemia Dietary Supplement: FishOil Dietary Supplement: CBE75 Dietary Supplement: CBE150 Dietary Supplement: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: FishOil + placebo
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
Dietary Supplement: FishOil Dietary Supplement: placebo
Experimental: FishOil + CBE75
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
Dietary Supplement: FishOil Dietary Supplement: CBE75
Experimental: FishOil + CBE150
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
Dietary Supplement: FishOil Dietary Supplement: CBE150


Outcome Measures

Primary Outcome Measures :
  1. LDL cholesterol [ Time Frame: Baseline, 8 weeks ]
    Change in LDL cholesterol level at the end of 8 weeks


Secondary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671254


Contacts
Contact: Joseph J Lamb, MD 253-853-7207 josephlamb@metagenics.com
Contact: Lincoln Bouillon, MBA 253-853-7206 lincolnbouillon@metagenics.com

Locations
United States, Washington
Functional Medicine Research Center Recruiting
Gig Harbor, Washington, United States, 98332
Contact: Joseph J Lamb, MD    253-853-7207    josephlamb@metagenics.com   
Sponsors and Collaborators
MetaProteomics LLC
Investigators
Principal Investigator: Joseph J Lamb, MD MetaProteomics / Metagenics / FMRC
More Information

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01671254     History of Changes
Other Study ID Numbers: POT2-FMR-CT
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents