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

Phase 2

Completed

• Conditions: Overweight; Hyperlipidemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Barley beta-glucan(3.0g)

• Registration Number: NCT01402128
• Lead Sponsor: Chonbuk National University Hospital

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.

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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-10
• Study Completion: 2011-05
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Results First Submitted: 2012-07-26
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Results First Posted: 2012-12-25
• Last Update Posted: 2012-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 12 weeks
Barley beta-glucan(3.0g)	Barley beta-glucan(3.0g)	Barley beta-glucan(3.0g/day) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in Body Fat Mass(kg)	12 weeks	Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat(%)	12 weeks	Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of