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Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects

NCT ID: NCT01402128

Last Updated: 2012-12-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Overweight; Hyperlipidemia

Keywords

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Soluble fiber Polycan Overweight LDL-C(Low Density Lipoprotein-cholesterol)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Barley beta-glucan(3.0g)

Barley beta-glucan(3.0g/day) for 12 weeks

Group Type EXPERIMENTAL

Barley beta-glucan(3.0g)

Intervention Type DIETARY_SUPPLEMENT

Barley beta-glucan(3.0g/day) for 12 weeks

Placebo

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks

Interventions

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Barley beta-glucan(3.0g)

Barley beta-glucan(3.0g/day) for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo-Wan Chae, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MTB-bG-001

Identifier Type: -

Identifier Source: org_study_id