Clincosm LogoSign in Get a demo

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

Sponsor
MetaProteomics LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01671254
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
4
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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 Phase
  • Dietary Supplement: FishOil
  • Dietary Supplement: CBE75
  • Dietary Supplement: CBE150
  • Dietary Supplement: placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 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 :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

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 [Baseline, 8 weeks]

    Change in LDL cholesterol level at the end of 8 weeks

Secondary Outcome Measures

  1. Triglyceride [Baseline, 8 weeks]

    Change in triglyceride level at the end of 8 weeks.

  2. oxLDL [Baseline, 8 weeks]

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

  3. Total cholesterol [Baseline, 8 weeks]

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

  4. HDL cholesterol [Baseline, 8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Functional Medicine Research Center Gig Harbor Washington United States 98332

Sponsors and Collaborators

  • MetaProteomics LLC

Investigators

  • Principal Investigator: Joseph J Lamb, MD, MetaProteomics / Metagenics / FMRC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MetaProteomics LLC
ClinicalTrials.gov Identifier:
NCT01671254
Other Study ID Numbers:
  • POT2-FMR-CT
First Posted:
Aug 23, 2012
Last Update Posted:
May 18, 2018
Last Verified:
May 1, 2018
Additional relevant MeSH terms:
Hyperlipidemias

Study Results

No Results Posted as of May 18, 2018