Skip to main content
OpenTrials
Completed

NCT Number: NCT03649620

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Cholesterol

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,.

Treatment and study plan

unripe Bokbunja Extract

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo for 12 weeks

Primary outcomes

  1. Changes of Total cholesterol

    Time frame: 12 weeks

    Changes of total cholesterol were assessed before and after the intervention

Secondary outcomes

  1. Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)

    Time frame: 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

  2. 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)

    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) were assessed before and after the intervention

  3. Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)

    Time frame: 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

  4. Changes of Oxidized LDL

    Time frame: 12 weeks

    Changes of oxidized LDL were assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 28, 2018
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.