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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014