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

Yonsei University80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Blood Cholesterol

Interventions

unripe Bokbunja ExtractDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Placebo for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Changes of total cholesterol were assessed before and after the intervention

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Changes of Oxidized LDL

Changes of oxidized LDL were assessed before and after the intervention

Time frame: 12 weeks

Data from ClinicalTrials.gov

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