Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava | NCT02091024

Studies
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava

NCT02091024

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Mar 19, 2014Estimated

Enrollment

80Actual

Phase

Phase 2Phase 3

Conditions

Hypercholesterolemia

Interventions

ECE (Ecklonia cava extract)
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 17, 2014

First Submission Date that Met QC Criteria

Mar 17, 2014

First Posted Date

Mar 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2014

Last Update Posted Date

Mar 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Clinical Trial Center for Functional Food, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECG (Ecklonia cava extract)	Experimental	ECE 200mg, twice a day	Dietary Supplement: ECE (Ecklonia cava extract)
Placebo	Placebo Comparator	Placebo 200mg, twice a day	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECE (Ecklonia cava extract)	Dietary Supplement	ECE 200mg, twice a day	ECG (Ecklonia cava extract)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in total cholesterol		12 weeks
Changes in LDL-cholesterol		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in triglyceride		12 weeks
Changes in HDL-cholesterol		12 weeks
Changes in waist to hip ratio

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital		Jeonju	Jeollabuk-do	560-822	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072396	Endothelin-Converting Enzymes

Ancestor Terms

ID	Term
D016282	Aspartic Acid Endopeptidases
D057055	Aspartic Acid Proteases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided