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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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


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




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



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,.

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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