Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FishOil
CBE75
CBE150
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Hyperlipidemia
Eligibility 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
Sites / Locations
- Functional Medicine Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
FishOil + placebo
FishOil + CBE75
FishOil + CBE150
Arm Description
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
Outcomes
Primary Outcome Measures
LDL cholesterol
Change in LDL cholesterol level at the end of 8 weeks
Secondary Outcome Measures
Triglyceride
Change in triglyceride level at the end of 8 weeks.
oxLDL
Change in oxidized LDL level at the end of 8 weeks.
Total cholesterol
Change in total cholesterol level at the end of 8 weeks.
HDL cholesterol
Change in HDL cholesterol level at the end of 8 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01671254
Brief Title
Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetaProteomics LLC
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FishOil + placebo
Arm Type
Active Comparator
Arm Description
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
Arm Title
FishOil + CBE75
Arm Type
Experimental
Arm Description
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
Arm Title
FishOil + CBE150
Arm Type
Experimental
Arm Description
Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
FishOil
Intervention Type
Dietary Supplement
Intervention Name(s)
CBE75
Intervention Type
Dietary Supplement
Intervention Name(s)
CBE150
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
LDL cholesterol
Description
Change in LDL cholesterol level at the end of 8 weeks
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Triglyceride
Description
Change in triglyceride level at the end of 8 weeks.
Time Frame
Baseline, 8 weeks
Title
oxLDL
Description
Change in oxidized LDL level at the end of 8 weeks.
Time Frame
Baseline, 8 weeks
Title
Total cholesterol
Description
Change in total cholesterol level at the end of 8 weeks.
Time Frame
Baseline, 8 weeks
Title
HDL cholesterol
Description
Change in HDL cholesterol level at the end of 8 weeks.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Lamb, MD
Organizational Affiliation
MetaProteomics / Metagenics / FMRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Functional Medicine Research Center
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98332
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
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