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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Glycin max(L.) Merr. peel extract; Dietary Supplement: Placebo

• Registration Number: NCT02108691
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Study Start: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-05
• Results First Submitted: 2015-05-06
• Results First Submitted QC: 2015-05-06
• Last Update Submitted: 2015-05-06
• Results First Posted: 2015-05-22
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycin max(L.) Merr. pell extract	Glycin max(L.) Merr. peel extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Body Fat Mass	8 weeks	Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanyang University; 🇰🇷 Seoul, Korea, Republic of