A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol

Yonsei University0 sites80 target enrollmentDecember 2016

ConditionsBlood Cholesterol

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Blood Cholesterol
Sponsor: Yonsei University
Enrollment: 80
Primary Endpoint: Changes of Total cholesterol
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.

Detailed Description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

February 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Principal Investigator

Jong Ho Lee

Professor, Principal Investigator

Yonsei University

Eligibility Criteria

Inclusion Criteria

•age between 20 and 65 years,
•Total cholesterol 200-239 mg/dl
•subjects giving written informed consent

Exclusion Criteria

•Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
•History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
•Participation in any other clinical trials within past 2 months
•Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
•Pregnancy or breast feeding etc,.

Outcomes

Primary Outcomes

Changes of Total cholesterol

Time Frame: 12 weeks

Changes of total cholesterol were assessed before and after the intervention

Secondary Outcomes

Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)(12 weeks)
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)(12 weeks)
Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)(12 weeks)
Changes of Oxidized LDL(12 weeks)