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

Study Overview
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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.

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

Conditions
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Overweight; Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Barley beta-glucan(3.0g)
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barley beta-glucan(3.0g)<br>Barley beta-glucan(3.0g/day) for 12 weeks | Dietary Supplement: Barley beta-glucan(3.0g)<br>* Barley beta-glucan(3.0g/day) for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks | Dietary Supplement: Placebo<br>* Placebo for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visceral Adipose Tissue | Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) | LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in HDL-C(High Density Lipoprotein-cholesterol) | HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in FFA(Free Fatty Acid) | FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Apo-A1(Apolipoprotein A1) | Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Apo-B(Apolipoprotein B) | Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Subcutaneous Adipose Tissue | Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soluble fiber, Polycan, Overweight, LDL-C(Low Density Lipoprotein-cholesterol)