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

Study Overview
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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.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Pyrus pyrifolia var. culta(Makino) NaKai peel extract
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyrus pyrifolia var. culta(Makino) NaKai peel extract<br> | Dietary Supplement: Pyrus pyrifolia var. culta(Makino) NaKai peel extract<br>* Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo(4g/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body fat mass | Body fat mass was measured in study baseline and visit 3(8 week) | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in percent body fat | Percent body fat was measured in study baseline and visit 3(8 week) | 8 week | 
| Change in fat free mass | Fat free mass was measured in study baseline and visit 3(8week) | 8 week | 
| Change in body mass index | Body mass index was measured in study baseline and visit 3(8 week) | 8 week | 
| Change in weight | Weight was measured in study baseline and visit 3(8 week) | 8 week | 
| Change in total cholesterol | Total cholesterol was measured in study baseline and visit 3(8 week) | 8 week | 
| Change in triglyceride | Triglyceride was measured in study baseline and visit 3(8 week) | 8 week |