Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. 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: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Glycin max(L.) Merr. peel extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 133-791
    • Hanyang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (2.5g/day)
Experimental: Glycin max(L.) Merr. pell extract	Dietary supplement: Glycin max(L.) Merr. peel extract; Glycin max(L.) Merr. peel extract (2.5g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Fat Mass	Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Percent Body Fat	Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks
Changes in Weight	Weight was measured in study visit 1(0 week)and visit 3(8 week).	8 weeks
Changes in BMI(Body Mass Index)	BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).	8 weeks
Changes in LDLc	LDLc was measured in study visit 1(0week) and visit 3(8 week).	8 weeks
Changes in Non-HDLc	Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).	8 weeks
Changes in LDLc/HDLc	LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).	8 weeks

Collaborators and Investigators

• Sponsor: Hanyang University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SSWU-BF-GE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No