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

This study is currently recruiting participants. (see Contacts and Locations)
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014