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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03649620
Enrollment
80
Registered
2018-08-28
Start date
2016-12-31
Completion date
2018-02-28
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Cholesterol

Keywords

cholesterol, Bokbunja, Clinical Trial

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.

Interventions

DIETARY_SUPPLEMENTunripe Bokbunja Extract

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

DIETARY_SUPPLEMENTPlacebo

Placebo for 12 weeks

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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,.

Design outcomes

Primary

MeasureTime frameDescription
Changes of Total cholesterol12 weeksChanges of total cholesterol were assessed before and after the intervention

Secondary

MeasureTime frameDescription
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)12 weeksChanges 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 weeksChanges 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 Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)12 weeksChanges 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 Oxidized LDL12 weeksChanges of oxidized LDL were assessed before and after the intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026