Completed
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
What is being tested
FishOil
+ placebo
+ FishOil
Dietary Supplement
Who is being recruted
Metabolic Diseases+2
+ Nutritional and Metabolic Diseases
+ Dyslipidemias
From 18 to 72 Years
+15 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: August 2012
Summary
Principal SponsorMetaProteomics LLC
Last updated: May 18, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorMetaProteomics LLC
Last updated: May 18, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 72 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHyperlipidemias
Criteria
6 inclusion criteria required to participate
BMI > 18 and < 38
LDL cholesterol >= 130 mg/dl and < 270 mg/dl
ability to understand and the willingness to sign a written informed consent
generally healthy
Show More Criteria
9 exclusion criteria prevent from participating
history of allergy or intolerance to study products
history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness
history of regular intake of > 14 alcoholic drinks per week for females and > 21 drinks per week for males
known infection with HIB, TB, hepatitis B or hepatitis C
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorSubjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
Group II
ExperimentalSubjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
Group III
ExperimentalSubjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Functional Medicine Research Center
Gig Harbor, United StatesOpen Functional Medicine Research Center in Google MapsCompletedOne Study Center