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

August 20, 2012
August 20, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
LDL cholesterol [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
Change in LDL cholesterol level at the end of 8 weeks
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Hyperlipidemia
  • Dietary Supplement: FishOil
  • Dietary Supplement: CBE75
  • Dietary Supplement: CBE150
  • Dietary Supplement: placebo
  • Active Comparator: FishOil + placebo
    Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
    Interventions:
    • 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)
    Interventions:
    • 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)
    Interventions:
    • Dietary Supplement: FishOil
    • Dietary Supplement: CBE150
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 72 Years
Yes
Contact: Joseph J Lamb, MD 253-853-7207 josephlamb@metagenics.com
Contact: Lincoln Bouillon, MBA 253-853-7206 lincolnbouillon@metagenics.com
United States
 
NCT01671254
POT2-FMR-CT
No
MetaProteomics LLC
MetaProteomics LLC
Not Provided
Principal Investigator: Joseph J Lamb, MD MetaProteomics / Metagenics / FMRC
MetaProteomics LLC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP