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

Hanyang University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Pyrus pyrifolia var. culta(Makino) NaKai peel extractDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Placebo(4g/day)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hanyang University

Seoul, South Korea

Outcomes

Primary Outcomes

Changes in body fat mass

Body fat mass was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Secondary Outcomes

Changes in percent body fat

Percent body fat was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Change in fat free mass

Fat free mass was measured in study baseline and visit 3(8week)

Time frame: 8 week

Change in body mass index

Body mass index was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Change in weight

Weight was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Change in total cholesterol

Total cholesterol was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Change in triglyceride

Triglyceride was measured in study baseline and visit 3(8 week)

Time frame: 8 week

Data from ClinicalTrials.gov

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