Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava

Hypercholesterolemia Clinical Trial

Official title:

Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava Extract in Hypercholesterolemic Korean Subjects: a Randomized Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091024
• Other study ID #: LVCM-HL-SEAPOLYNOL
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 17, 2014
• Last updated: March 17, 2014
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2014
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• ECE (Ecklonia cava extract)
ECE 200mg, twice a day
• Placebo
Placebo 200mg, twice a day

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total cholesterol		12 weeks	Yes
Primary	Changes in LDL-cholesterol		12 weeks	Yes
Secondary	Changes in triglyceride		12 weeks	Yes
Secondary	Changes in HDL-cholesterol		12 weeks	Yes
Secondary	Changes in waist to hip ratio		12 weeks	Yes