Trial Outcomes & Findings for Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects (NCT NCT01402128)

NCT ID: NCT01402128

Last Updated: 2012-12-25

Results Overview

Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

80 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-12-25

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Barley Beta-glucan Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process.	Placebo Placebo(1times/day, 1packs/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Barley beta-glucan
Overall Study STARTED	40	40
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Barley Beta-glucan(3.0g) n=40 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	47.9 years STANDARD_DEVIATION 8.7 • n=5 Participants	48.5 years STANDARD_DEVIATION 10.8 • n=7 Participants	48.2 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Korea, Republic of	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Body Fat Mass(kg) Pre	22.9 kg Standard Deviation 4.4	24.3 kg Standard Deviation 5.6
Changes in Body Fat Mass(kg) Post	22.8 kg Standard Deviation 4.8	24.1 kg Standard Deviation 5.7

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Percent Body Fat(%) Pre	33.1 percentage of body fat Standard Deviation 4.1	33.7 percentage of body fat Standard Deviation 4.6
Changes in Percent Body Fat(%) Post	33.1 percentage of body fat Standard Deviation 4.3	33.7 percentage of body fat Standard Deviation 4.7

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Visceral Adipose Tissue Pre	1250.7 cm^3 Standard Deviation 484.7	1296.1 cm^3 Standard Deviation 464.1
Changes in Visceral Adipose Tissue Post	1140.3 cm^3 Standard Deviation 374.4	1165.7 cm^3 Standard Deviation 365.9

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) Pre	141.7 mg/dl Standard Deviation 18.8	141.4 mg/dl Standard Deviation 28.5
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) Post	141.7 mg/dl Standard Deviation 30.8	141.6 mg/dl Standard Deviation 31.4

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in HDL-C(High Density Lipoprotein-cholesterol) Pre	46.7 mg/dl Standard Deviation 9.7	47.1 mg/dl Standard Deviation 11.4
Changes in HDL-C(High Density Lipoprotein-cholesterol) Post	46.7 mg/dl Standard Deviation 12.3	46.1 mg/dl Standard Deviation 10.6

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Total Cholesterol Pre	220.9 mg/dL Standard Deviation 23.5	220.0 mg/dL Standard Deviation 30.5
Changes in Total Cholesterol Post	211.6 mg/dL Standard Deviation 35.2	210.9 mg/dL Standard Deviation 31.6

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Triglyceride Pre	141.9 mg/dL Standard Deviation 67.9	133.0 mg/dL Standard Deviation 55.7
Changes in Triglyceride Post	141.1 mg/dL Standard Deviation 67.2	133.2 mg/dL Standard Deviation 62.7

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in FFA(Free Fatty Acid) Pre	605.1 µEq/L Standard Deviation 243.8	591.1 µEq/L Standard Deviation 214.6
Changes in FFA(Free Fatty Acid) Post	647.7 µEq/L Standard Deviation 194.3	644.4 µEq/L Standard Deviation 243.8

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Apo-A1(Apolipoprotein A1) Pre	1.44 g/l Standard Deviation 0.20	1.42 g/l Standard Deviation 0.21
Changes in Apo-A1(Apolipoprotein A1) Post	1.37 g/l Standard Deviation 0.25	1.36 g/l Standard Deviation 0.23

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Apo-B(Apolipoprotein B) Pre	1.06 g/L Standard Deviation 0.16	1.05 g/L Standard Deviation 0.16
Changes in Apo-B(Apolipoprotein B) Post	0.98 g/L Standard Deviation 0.19	0.99 g/L Standard Deviation 0.19

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Barley Beta-glucan(3.0g) n=39 Participants Barley beta-glucan(3.0g/day) for 12 weeks	Placebo n=40 Participants Placebo for 12 weeks
Changes in Subcutaneous Adipose Tissue Pre	2732.0 cm^3 Standard Deviation 603.4	2929.1 cm^3 Standard Deviation 792.6
Changes in Subcutaneous Adipose Tissue Post	2723.7 cm^3 Standard Deviation 644.7	2941.7 cm^3 Standard Deviation 817.3

Adverse Events

Barley Beta-glucan(3.0g)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Soo-Wan Chae, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place