Back to resultsEfficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
Primary Purpose
Overweight; Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Barley beta-glucan(3.0g)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Overweight; Hyperlipidemia focused on measuring Soluble fiber, Polycan, Overweight, LDL-C(Low Density Lipoprotein-cholesterol)
Eligibility Criteria
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.
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Barley beta-glucan(3.0g)
Placebo
Arm Description
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Outcomes
Primary Outcome Measures
Changes in Body Fat Mass(kg)
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat(%)
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Secondary Outcome Measures
Changes in Visceral Adipose Tissue
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in HDL-C(High Density Lipoprotein-cholesterol)
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Triglyceride
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Changes in FFA(Free Fatty Acid)
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-A1(Apolipoprotein A1)
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-B(Apolipoprotein B)
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Subcutaneous Adipose Tissue
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Full Information
NCT ID
NCT01402128
First Posted
July 21, 2011
Last Updated
November 26, 2012
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01402128
Brief Title
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
Official Title
The Effect of Barley Beta-glucan on Serum Lipids and Body Weight
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight; Hyperlipidemia
Keywords
Soluble fiber, Polycan, Overweight, LDL-C(Low Density Lipoprotein-cholesterol)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Barley beta-glucan(3.0g)
Arm Type
Experimental
Arm Description
Barley beta-glucan(3.0g/day) for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Barley beta-glucan(3.0g)
Intervention Description
Barley beta-glucan(3.0g/day) for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Primary Outcome Measure Information:
Title
Changes in Body Fat Mass(kg)
Description
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Percent Body Fat(%)
Description
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Visceral Adipose Tissue
Description
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
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
Title
Changes in HDL-C(High Density Lipoprotein-cholesterol)
Description
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Total Cholesterol
Description
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Triglyceride
Description
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in FFA(Free Fatty Acid)
Description
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Apo-A1(Apolipoprotein A1)
Description
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Apo-B(Apolipoprotein B)
Description
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Subcutaneous Adipose Tissue
Description
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Wan Chae, MD., PhD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
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Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
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