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

This study is currently recruiting participants.
Verified August 2012 by MetaProteomics LLC
Sponsor:
Information provided by (Responsible Party):
MetaProteomics LLC
ClinicalTrials.gov Identifier:
NCT01671254
First received: August 20, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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 Intervention
Hyperlipidemia
 Dietary Supplement: FishOil
Dietary Supplement: CBE75
Dietary Supplement: CBE150
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MetaProteomics LLC:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change in LDL cholesterol level at the end of 8 weeks


Secondary Outcome Measures:
  • Triglyceride [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change in triglyceride level at the end of 8 weeks.

  • oxLDL [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change in oxidized LDL level at the end of 8 weeks.

  • Total cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change in total cholesterol level at the end of 8 weeks.

  • HDL cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change in HDL cholesterol level at the end of 8 weeks.


Estimated Enrollment: 72
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01671254     History of Changes
Other Study ID Numbers: POT2-FMR-CT
Study First Received: August 20, 2012
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013