Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid.

NCT ID: NCT02742688

Last Updated: 2016-04-19

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.

Detailed Description

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Conditions

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Obesity

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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Pyrus pyrifolia var. culta(Makino) NaKai peel extract

Group Type EXPERIMENTAL

Pyrus pyrifolia var. culta(Makino) NaKai peel extract

Intervention Type DIETARY_SUPPLEMENT

Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo(4g/day)

Interventions

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Pyrus pyrifolia var. culta(Makino) NaKai peel extract

Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo(4g/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males and females 19-65 years old
* BMI(body mass index) 25\~29.9 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria

* BMI(body mass index) ≥ 30 kg/m\^2
* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* 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
* Pregnant or lactating women etc.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yongsoon Park

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hanyang University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GFB-BF-PE

Identifier Type: -

Identifier Source: org_study_id

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