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

Chonbuk National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight; Hyperlipidemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Barley beta-glucan(3.0g)

Study type: Interventional

Funder types: Other

Identifiers

NCT01402128

MTB-bG-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Barley beta-glucan(3.0g)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Barley beta-glucan(3.0g)

Placebo

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo