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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedResults Posted
Study results publicly available
December 25, 2012
CompletedDecember 25, 2012
November 1, 2012
4 months
July 21, 2011
July 26, 2012
November 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in Body Fat Mass(kg)
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Percent Body Fat(%)
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Secondary Outcomes (9)
Changes in Visceral Adipose Tissue
12 weeks
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
12 weeks
Changes in HDL-C(High Density Lipoprotein-cholesterol)
12 weeks
Changes in Total Cholesterol
12 weeks
Changes in Triglyceride
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Barley beta-glucan(3.0g)
EXPERIMENTALBarley beta-glucan(3.0g/day) for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks
Interventions
Barley beta-glucan(3.0g/day) for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Soo-Wan Chae, MD
- Organization
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Soo-Wan Chae, MD., PhD
Chonbuk National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 26, 2011
Study Start
June 1, 2010
Primary Completion
October 1, 2010
Study Completion
May 1, 2011
Last Updated
December 25, 2012
Results First Posted
December 25, 2012
Record last verified: 2012-11