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

NCT ID: NCT03649620

Last Updated: 2018-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Blood Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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unripe Bokbunja Extract

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

Group Type EXPERIMENTAL

unripe Bokbunja Extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks

Placebo

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

unripe Bokbunja Extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks

Interventions

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unripe Bokbunja Extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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,.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Lee

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.

Reference Type DERIVED
PMID: 32646501 (View on PubMed)

Other Identifiers

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BC_cholesterol

Identifier Type: -

Identifier Source: org_study_id

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