NCT02091024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

8 months

First QC Date

March 17, 2014

Last Update Submit

March 17, 2014

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • Changes in total cholesterol

    12 weeks

  • Changes in LDL-cholesterol

    12 weeks

Secondary Outcomes (3)

  • Changes in triglyceride

    12 weeks

  • Changes in HDL-cholesterol

    12 weeks

  • Changes in waist to hip ratio

    12 weeks

Study Arms (2)

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

ECE (Ecklonia cava extract)DIETARY_SUPPLEMENT

ECE 200mg, twice a day

ECG (Ecklonia cava extract)
PlaceboDIETARY_SUPPLEMENT

Placebo 200mg, twice a day

Placebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)

You may not qualify if:

  • Self-reported pregnancy, lactation
  • Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Endothelin-Converting Enzymes

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Aspartic Acid EndopeptidasesAspartic Acid ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidasesMetalloendopeptidasesMetalloproteases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Food

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

KR(1)