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

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ClinicalTrials.gov Identifier: NCT03649620
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jong Ho Lee, Yonsei University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes of Total cholesterol [ Time Frame: 12 weeks ]
    Changes of total cholesterol were assessed before and after the intervention


Secondary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jong Ho Lee, Professor, Principal Investigator, Yonsei University
ClinicalTrials.gov Identifier: NCT03649620    
Other Study ID Numbers: BC_cholesterol
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jong Ho Lee, Yonsei University:
cholesterol
Bokbunja
Clinical Trial