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

Not Applicable

Completed

• Conditions: Blood Cholesterol
• Interventions: Dietary Supplement: unripe Bokbunja Extract; Dietary Supplement: Placebo

• Registration Number: NCT03649620
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-05
• Study Completion: 2018-02
• Status Verified: 2018-05
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-24
• Last Update Submitted: 2018-08-24
• Study First Posted: 2018-08-28
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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,.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unripe Bokbunja Extract	unripe Bokbunja Extract	tablet(1 tablet/d, 600 mg/d) for 12 weeks
Placebo	unripe Bokbunja Extract	Placebo for 12 weeks
unripe Bokbunja Extract	Placebo	tablet(1 tablet/d, 600 mg/d) for 12 weeks
Placebo	Placebo	Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes of Total cholesterol	12 weeks	Changes of total cholesterol were assessed before and after the intervention

Secondary Outcome Measures

Name	Time	Method
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 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 Oxidized LDL	12 weeks	Changes of oxidized LDL were assessed before and after the intervention