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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barley beta-glucan(3.0g) | Experimental | Barley beta-glucan(3.0g/day) for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barley beta-glucan(3.0g) | Dietary Supplement | Barley beta-glucan(3.0g/day) for 12 weeks |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Wan Chae, MD., PhD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
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 were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Placebo(1times/day, 1packs/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Barley beta-glucan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Barley Beta-glucan(3.0g) | Barley beta-glucan(3.0g/day) for 12 weeks |
| BG001 | Placebo | Placebo for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Body Fat Mass(kg) | Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Barley Beta-glucan(3.0g) | Barley beta-glucan(3.0g/day) for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Soo-Wan Chae, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | soowan@jbnu.ac.kr |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Placebo for 12 weeks |
|
| 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 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Changes in Visceral Adipose Tissue | Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | cm^3 | 12 weeks |
|
|
|
| Secondary | 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). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | 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). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Changes in FFA(Free Fatty Acid) | FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | µEq/L | 12 weeks |
|
|
|
| Secondary | Changes in Apo-A1(Apolipoprotein A1) | Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | g/l | 12 weeks |
|
|
|
| Secondary | Changes in Apo-B(Apolipoprotein B) | Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | g/L | 12 weeks |
|
|
|
| Primary | Changes in Percent Body Fat(%) | Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | percentage of body fat | 12 weeks |
|
|
|
| Secondary | Changes in Subcutaneous Adipose Tissue | Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | cm^3 | 12 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo for 12 weeks | 0 | 0 | 0 | 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |