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

NCT02108691 | Completed Phase 2 Results DMC

• 1 other identifier: SSWU-BF-GE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in Body Fat Mass

  Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).

  8 weeks

Secondary Outcomes (6)

• Changes in Percent Body Fat

  8 weeks

• Changes in Weight

  8 weeks

• Changes in BMI(Body Mass Index)

  8 weeks

• Changes in LDLc

  8 weeks

• Changes in Non-HDLc

  8 weeks

Study Arms (2)

Glycin max(L.) Merr. pell extract

EXPERIMENTAL

Dietary Supplement: Glycin max(L.) Merr. peel extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Glycin max(L.) Merr. peel extract DIETARY_SUPPLEMENT

Glycin max(L.) Merr. peel extract (2.5g/day)

Glycin max(L.) Merr. pell extract

Placebo DIETARY_SUPPLEMENT

Placebo (2.5g/day)

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University

Seoul, 133-791, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Yongsoon Park
• Organization: Hanyang University

yongsoon@hanyang.ac.kr

82-2-2220-1205

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 22, 2015
• Results First Posted: May 22, 2015

Record last verified: 2015-05

Locations

KR (1)