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

Phase 2

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pyrus pyrifolia var. culta(Makino) NaKai peel extract

• Registration Number: NCT02742688
• Lead Sponsor: Hanyang University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pyrus pyrifolia var. culta(Makino) NaKai peel extract	Pyrus pyrifolia var. culta(Makino) NaKai peel extract	-

Primary Outcome Measures

Name	Time	Method
Changes in body fat mass	8 week	Body fat mass was measured in study baseline and visit 3(8 week)

Secondary Outcome Measures

Name	Time	Method
Change in triglyceride	8 week	Triglyceride was measured in study baseline and visit 3(8 week)
Change in total cholesterol	8 week	Total cholesterol was measured in study baseline and visit 3(8 week)
Change in body mass index	8 week	Body mass index was measured in study baseline and visit 3(8 week)
Changes in percent body fat	8 week	Percent body fat was measured in study baseline and visit 3(8 week)
Change in fat free mass	8 week	Fat free mass was measured in study baseline and visit 3(8week)
Change in weight	8 week	Weight was measured in study baseline and visit 3(8 week)

Trial Locations

Locations (1)

Hanyang University; 🇰🇷 Seoul, Korea, Republic of