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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01402128
First received: July 21, 2011
Last updated: November 26, 2012
Last verified: November 2012
Results First Received: July 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Overweight; Hyperlipidemia
Interventions: Dietary Supplement: Barley beta-glucan(3.0g)
Dietary Supplement: Placebo

  Participant Flow
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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
  Description
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

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  
NOT COMPLETED     1     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     40     80  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.9  ± 8.7     48.5  ± 10.8     48.2  ± 9.8  
Gender  
[units: participants]
     
Female     37     36     73  
Male     3     4     7  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     40     40     80  



  Outcome Measures
  Show All 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
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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
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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
e-mail: soowan@jbnu.ac.kr


No publications provided


Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01402128     History of Changes
Other Study ID Numbers: MTB-bG-001
Study First Received: July 21, 2011
Results First Received: July 26, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board