Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03649620

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Blood Cholesterol	Dietary Supplement: unripe Bokbunja Extract Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: unripe Bokbunja Extract tablet(1 tablet/d, 600 mg/d) for 12 weeks	Dietary Supplement: unripe Bokbunja Extract tablet(1 tablet/d, 600 mg/d) for 12 weeks Dietary Supplement: Placebo Placebo for 12 weeks
Placebo Comparator: Placebo Placebo for 12 weeks	Dietary Supplement: unripe Bokbunja Extract tablet(1 tablet/d, 600 mg/d) for 12 weeks Dietary Supplement: Placebo Placebo for 12 weeks

Arm

Intervention/Treatment

Experimental: unripe Bokbunja Extract

tablet(1 tablet/d, 600 mg/d) for 12 weeks

Dietary Supplement: unripe Bokbunja Extract

tablet(1 tablet/d, 600 mg/d) for 12 weeks

Dietary Supplement: Placebo

Placebo for 12 weeks

Placebo Comparator: Placebo

Placebo for 12 weeks

Dietary Supplement: unripe Bokbunja Extract

tablet(1 tablet/d, 600 mg/d) for 12 weeks

Dietary Supplement: Placebo

Placebo for 12 weeks

Outcome Measures

Primary Outcome Measures

Changes of Total cholesterol [12 weeks]
Changes of total cholesterol were assessed before and after the intervention

Secondary Outcome Measures

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 lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP) were assessed before and after the intervention
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 arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1) were assessed before and after the intervention
Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) [12 weeks]
Changes of anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) were assessed before and after the intervention
Changes of Oxidized LDL [12 weeks]
Changes of oxidized LDL were assessed before and after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jong Ho Lee, Professor, Principal Investigator, Yonsei University

ClinicalTrials.gov Identifier:

NCT03649620

Other Study ID Numbers:

BC_cholesterol

First Posted:

Aug 28, 2018

Last Update Posted:

Aug 28, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Jong Ho Lee, Professor, Principal Investigator, Yonsei University

cholesterol

Bokbunja

Clinical Trial

Study Results

No Results Posted as of Aug 28, 2018