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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01402128
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Overweight; Hyperlipidemia
Interventions: Dietary Supplement: Barley beta-glucan(3.0g)
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The criteria were an age from 19 to 70 years, BMI(Body Mass Index) >23 kg/m^2, and LDL-C(Low Density Lipoprotein-cholesterol) concentration between 110 and 250 mg/dL

Reporting Groups
Barley Beta-glucan

Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks

Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process.


Placebo(1times/day, 1packs/day, 3g/day) for 12weeks

Placebo : Amount and calorie of placebo are same with Barley beta-glucan

Participant Flow:   Overall Study
    Barley Beta-glucan   Placebo
STARTED   40   40 
COMPLETED   39   40 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Barley Beta-glucan(3.0g) Barley beta-glucan(3.0g/day) for 12 weeks
Placebo Placebo for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Barley Beta-glucan(3.0g)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   40   40   80 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 47.9  (8.7)   48.5  (10.8)   48.2  (9.8) 
[Units: Participants]
Female   37   36   73 
Male   3   4   7 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   40   40   80 

  Outcome Measures

1.  Primary:   Changes in Body Fat Mass(kg)   [ Time Frame: 12 weeks ]

2.  Primary:   Changes in Percent Body Fat(%)   [ Time Frame: 12 weeks ]

3.  Secondary:   Changes in Visceral Adipose Tissue   [ Time Frame: 12 weeks ]

4.  Secondary:   Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)   [ Time Frame: 12 weeks ]

5.  Secondary:   Changes in HDL-C(High Density Lipoprotein-cholesterol)   [ Time Frame: 12 weeks ]

6.  Secondary:   Changes in Total Cholesterol   [ Time Frame: 12 weeks ]

7.  Secondary:   Changes in Triglyceride   [ Time Frame: 12 weeks ]

8.  Secondary:   Changes in FFA(Free Fatty Acid)   [ Time Frame: 12 weeks ]

9.  Secondary:   Changes in Apo-A1(Apolipoprotein A1)   [ Time Frame: 12 weeks ]

10.  Secondary:   Changes in Apo-B(Apolipoprotein B)   [ Time Frame: 12 weeks ]

11.  Secondary:   Changes in Subcutaneous Adipose Tissue   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Soo-Wan Chae, MD
Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
phone: 82-63-276-8284

Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital Identifier: NCT01402128     History of Changes
Other Study ID Numbers: MTB-bG-001
First Submitted: July 21, 2011
First Posted: July 26, 2011
Results First Submitted: July 26, 2012
Results First Posted: December 25, 2012
Last Update Posted: December 25, 2012