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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01402128

Enrollment

Registered

2011-07-26

Start date

2010-06-30

Completion date

2011-05-31

Last updated

2012-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight; Hyperlipidemia

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTBarley beta-glucan(3.0g)

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

DIETARY_SUPPLEMENTPlacebo

Placebo for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Visceral Adipose Tissue	12 weeks	Visceral adipose tissue 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).
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 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).

Countries

South Korea

Participant flow

Recruitment details

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-assignment details

The criteria were an age from 19 to 70 years, BMI(Body Mass Index) \>23 kg/m\^2, and LDL-C(Low Density Lipoprotein-cholesterol) concentration between 110 and 250 mg/dL

Participants by arm

Arm	Count
Barley Beta-glucan(3.0g) Barley beta-glucan(3.0g/day) for 12 weeks	40
Placebo Placebo for 12 weeks	40
Total	80

Baseline characteristics

Characteristic	Placebo	Barley Beta-glucan(3.0g)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	40 Participants	40 Participants	80 Participants
Age Continuous	48.5 years STANDARD_DEVIATION 10.8	47.9 years STANDARD_DEVIATION 8.7	48.2 years STANDARD_DEVIATION 9.8
Region of Enrollment Korea, Republic of	40 participants	40 participants	80 participants
Sex: Female, Male Female	36 Participants	37 Participants	73 Participants
Sex: Female, Male Male	4 Participants	3 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary