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

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

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

Study Overview

• Status: Completed
• Conditions: Blood Cholesterol
• Intervention / Treatment: Dietary supplement: unripe Bokbunja Extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Total cholesterol	Changes of total cholesterol were assessed before and after the intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)	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	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)	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	12 weeks
Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)	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	12 weeks
Changes of Oxidized LDL	Changes of oxidized LDL were assessed before and after the intervention	12 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Clinical Trial; cholesterol; Bokbunja
• Other Study ID Numbers: BC_cholesterol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided