Back to resultsBlood Lipid-lowering Effect of Brown Alga Ecklonia Cava
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ECE (Ecklonia cava extract)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)
Exclusion Criteria:
- Self-reported pregnancy, lactation
- Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ECG (Ecklonia cava extract)
Placebo
Arm Description
ECE 200mg, twice a day
Placebo 200mg, twice a day
Outcomes
Primary Outcome Measures
Changes in total cholesterol
Changes in LDL-cholesterol
Secondary Outcome Measures
Changes in triglyceride
Changes in HDL-cholesterol
Changes in waist to hip ratio
Full Information
NCT ID
NCT02091024
First Posted
March 17, 2014
Last Updated
March 17, 2014
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02091024
Brief Title
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava
Official Title
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava Extract in Hypercholesterolemic Korean Subjects: a Randomized Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.
Detailed Description
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The investigators measured improvement of lipid profile, including total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECG (Ecklonia cava extract)
Arm Type
Experimental
Arm Description
ECE 200mg, twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 200mg, twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
ECE (Ecklonia cava extract)
Intervention Description
ECE 200mg, twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo 200mg, twice a day
Primary Outcome Measure Information:
Title
Changes in total cholesterol
Time Frame
12 weeks
Title
Changes in LDL-cholesterol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in triglyceride
Time Frame
12 weeks
Title
Changes in HDL-cholesterol
Time Frame
12 weeks
Title
Changes in waist to hip ratio
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)
Exclusion Criteria:
Self-reported pregnancy, lactation
Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava
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