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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Overweight; Hyperlipidemia
 Dietary Supplement: Barley beta-glucan(3.0g)
Dietary Supplement: Placebo
 Phase 2
Phase 3

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
Official Title: The Effect of Barley Beta-glucan on Serum Lipids and Body Weight

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 80
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Barley beta-glucan(3.0g)
Barley beta-glucan(3.0g/day) for 12 weeks
 Dietary Supplement: Barley beta-glucan(3.0g)
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo Comparator: Placebo
Placebo for 12 weeks
 Dietary Supplement: Placebo
Placebo for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402128

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, 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

Keywords provided by Chonbuk National University Hospital:
Soluble fiber
Polycan
Overweight
LDL-C(Low Density Lipoprotein-cholesterol)

Additional relevant MeSH terms:
Hyperlipidemias
Overweight
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013