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Trial record 6 of 54 for:    barley

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

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ClinicalTrials.gov Identifier: NCT01402128
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Sponsor:
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
Enrollment 80
Recruitment Details Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment Details 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
Arm/Group Title Barley Beta-glucan Placebo
Hide Arm/Group Description

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

Period Title: Overall Study
Started 40 40
Completed 39 40
Not Completed 1 0
Arm/Group Title Barley Beta-glucan(3.0g) Placebo Total
Hide Arm/Group Description Barley beta-glucan(3.0g/day) for 12 weeks Placebo for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
40
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
47.9  (8.7) 48.5  (10.8) 48.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
37
  92.5%
36
  90.0%
73
  91.3%
Male
3
   7.5%
4
  10.0%
7
   8.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Changes in Body Fat Mass(kg)
Hide Description Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: kg
Pre 22.9  (4.4) 24.3  (5.6)
Post 22.8  (4.8) 24.1  (5.7)
2.Primary Outcome
Title Changes in Percent Body Fat(%)
Hide Description Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: percentage of body fat
Pre 33.1  (4.1) 33.7  (4.6)
Post 33.1  (4.3) 33.7  (4.7)
3.Secondary Outcome
Title Changes in Visceral Adipose Tissue
Hide Description Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: cm^3
Pre 1250.7  (484.7) 1296.1  (464.1)
Post 1140.3  (374.4) 1165.7  (365.9)
4.Secondary Outcome
Title Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
Hide Description LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: mg/dl
Pre 141.7  (18.8) 141.4  (28.5)
Post 141.7  (30.8) 141.6  (31.4)
5.Secondary Outcome
Title Changes in HDL-C(High Density Lipoprotein-cholesterol)
Hide Description HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: mg/dl
Pre 46.7  (9.7) 47.1  (11.4)
Post 46.7  (12.3) 46.1  (10.6)
6.Secondary Outcome
Title Changes in Total Cholesterol
Hide Description Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: mg/dL
Pre 220.9  (23.5) 220.0  (30.5)
Post 211.6  (35.2) 210.9  (31.6)
7.Secondary Outcome
Title Changes in Triglyceride
Hide Description Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: mg/dL
Pre 141.9  (67.9) 133.0  (55.7)
Post 141.1  (67.2) 133.2  (62.7)
8.Secondary Outcome
Title Changes in FFA(Free Fatty Acid)
Hide Description FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
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Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: µEq/L
Pre 605.1  (243.8) 591.1  (214.6)
Post 647.7  (194.3) 644.4  (243.8)
9.Secondary Outcome
Title Changes in Apo-A1(Apolipoprotein A1)
Hide Description Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: g/l
Pre 1.44  (0.20) 1.42  (0.21)
Post 1.37  (0.25) 1.36  (0.23)
10.Secondary Outcome
Title Changes in Apo-B(Apolipoprotein B)
Hide Description Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: g/L
Pre 1.06  (0.16) 1.05  (0.16)
Post 0.98  (0.19) 0.99  (0.19)
11.Secondary Outcome
Title Changes in Subcutaneous Adipose Tissue
Hide Description Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description:
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: cm^3
Pre 2732.0  (603.4) 2929.1  (792.6)
Post 2723.7  (644.7) 2941.7  (817.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other [non-serious] adverse events were not collected/assessed
 
Arm/Group Title Barley Beta-glucan(3.0g) Placebo
Hide Arm/Group Description Barley beta-glucan(3.0g/day) for 12 weeks Placebo for 12 weeks
All-Cause Mortality
Barley Beta-glucan(3.0g) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Barley Beta-glucan(3.0g) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Barley Beta-glucan(3.0g) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
ClinicalTrials.gov 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