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

July 21, 2011
November 26, 2012
June 2010
October 2010   (final data collection date for primary outcome measure)
  • Changes in Body Fat Mass(kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Percent Body Fat(%) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01402128 on ClinicalTrials.gov Archive Site
  • Changes in Visceral Adipose Tissue [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Total Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in FFA(Free Fatty Acid) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Apo-A1(Apolipoprotein A1) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Apo-B(Apolipoprotein B) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
  • Changes in Subcutaneous Adipose Tissue [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
  • Visceral fat [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • HDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • free fatty acid [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Apo A1 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Apo B [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Overweight; Hyperlipidemia
  • Dietary Supplement: Barley beta-glucan(3.0g)
    Barley beta-glucan(3.0g/day) 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
    Intervention: Dietary Supplement: Barley beta-glucan(3.0g)
  • Placebo Comparator: Placebo
    Placebo for 12 weeks
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
19 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01402128
MTB-bG-001
Yes
Soo-Wan Chae, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Principal Investigator: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital
Chonbuk National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP