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

April 14, 2016 updated by: Yongsoon Park, Hanyang University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Placebo(4g/day)
EXPERIMENTAL: Pyrus pyrifolia var. culta(Makino) NaKai peel extract
Dietary supplement: Pyrus pyrifolia var. culta(Makino) NaKai peel extract
Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (ESTIMATE)

April 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GFB-BF-PE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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