Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects

November 26, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital

The Effect of Barley Beta-glucan on Serum Lipids and Body Weight

Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study investigated whether the supplementation of barley β-glucan is reduce the visceral fat as well as the serum low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) in mildly hypercholesterolemic subjects. In a 12 week double-blind, controlled study, subjects were randomized to one of treatment group(3.0g/day as β-glucan) or placebo group.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • an age from 19 to 70 years,
  • a BMI(Body Mass Index) >23 kg/m^2,
  • an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 110 and 250 mg/dL

Exclusion Criteria:

  • they had heart disease, liver or kidney disease, food allergies, daily exercise habits, a body weight increase or decrease >10 kg in the previous 3 months, irregular lifestyle habits
  • they took medication and functional foods known to affect lipid metabolism.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks
Dietary supplement: Placebo
Placebo for 12 weeks
Experimental: Barley beta-glucan(3.0g)
Barley beta-glucan(3.0g/day) for 12 weeks
Dietary supplement: Barley beta-glucan(3.0g)
Barley beta-glucan(3.0g/day) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Body Fat Mass(kg)
Time Frame: 12 weeks
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Percent Body Fat(%)
Time Frame: 12 weeks
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Total Cholesterol
Time Frame: 12 weeks
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
Time Frame: 12 weeks
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Triglyceride
Time Frame: 12 weeks
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in HDL-C(High Density Lipoprotein-cholesterol)
Time Frame: 12 weeks
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Apo-A1(Apolipoprotein A1)
Time Frame: 12 weeks
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Apo-B(Apolipoprotein B)
Time Frame: 12 weeks
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in FFA(Free Fatty Acid)
Time Frame: 12 weeks
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Visceral Adipose Tissue
Time Frame: 12 weeks
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Subcutaneous Adipose Tissue
Time Frame: 12 weeks
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Collaborators and Investigators

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

Sponsor

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Soo-Wan Chae, MD., PhD, Chonbuk National University Hospital

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

June 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 25, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTB-bG-001

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.

Clinical Trials on Overweight; Hyperlipidemia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe