A Phase 2/3 interventional study of Barley beta-glucan(3.0g) and Placebo in Overweight; Hyperlipidemia, sponsored by Chonbuk National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-25.
Sponsored by Chonbuk National University Hospital · Phase 2/3, Interventional, and Supportive care
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 80 is close to the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Chonbuk National University Hospital is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Barley beta-glucan(3.0g/day) for 12 weeks
Dietary Supplement: Barley beta-glucan(3.0g)
Placebo for 12 weeks
Dietary Supplement: Placebo
Barley beta-glucan(3.0g/day) for 12 weeks
Placebo for 12 weeks
Changes in Body Fat Mass(kg)
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Changes in Percent Body Fat(%)
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Changes in Visceral Adipose Tissue
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Changes in Triglyceride
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
Changes in Subcutaneous Adipose Tissue
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
| Milestone | Barley Beta-glucan | Placebo |
|---|---|---|
| Started | 40 | 40 |
| Completed | 39 | 40 |
| Not completed | 1 | 0 |
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
| kg | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 22.9 ± 4.4 | 24.3 ± 5.6 |
| Post | 22.8 ± 4.8 | 24.1 ± 5.7 |
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
| cm^3 | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 1250.7 ± 484.7 | 1296.1 ± 464.1 |
| Post | 1140.3 ± 374.4 | 1165.7 ± 365.9 |
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
| mg/dl | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 141.7 ± 18.8 | 141.4 ± 28.5 |
| Post | 141.7 ± 30.8 | 141.6 ± 31.4 |
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
| mg/dl | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 46.7 ± 9.7 | 47.1 ± 11.4 |
| Post | 46.7 ± 12.3 | 46.1 ± 10.6 |
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
| mg/dL | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 220.9 ± 23.5 | 220.0 ± 30.5 |
| Post | 211.6 ± 35.2 | 210.9 ± 31.6 |
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
| mg/dL | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 141.9 ± 67.9 | 133.0 ± 55.7 |
| Post | 141.1 ± 67.2 | 133.2 ± 62.7 |
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
| µEq/L | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 605.1 ± 243.8 | 591.1 ± 214.6 |
| Post | 647.7 ± 194.3 | 644.4 ± 243.8 |
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
| g/l | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 1.44 ± 0.20 | 1.42 ± 0.21 |
| Post | 1.37 ± 0.25 | 1.36 ± 0.23 |
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
| g/L | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 1.06 ± 0.16 | 1.05 ± 0.16 |
| Post | 0.98 ± 0.19 | 0.99 ± 0.19 |
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
| percentage of body fat | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 33.1 ± 4.1 | 33.7 ± 4.6 |
| Post | 33.1 ± 4.3 | 33.7 ± 4.7 |
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
| cm^3 | Barley Beta-glucan(3.0g) | Placebo |
|---|---|---|
| Pre | 2732.0 ± 603.4 | 2929.1 ± 792.6 |
| Post | 2723.7 ± 644.7 | 2941.7 ± 817.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Barley Beta-glucan(3.0g) | — | — | — |
| Placebo | — | — | — |
| Age, Categorical(Participants) | Barley Beta-glucan(3.0g) | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 40 | 80 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Barley Beta-glucan(3.0g) | Placebo | Total |
|---|---|---|---|
| Mean | 47.9 ± 8.7 | 48.5 ± 10.8 | 48.2 ± 9.8 |
| Sex: Female, Male(Participants) | Barley Beta-glucan(3.0g) | Placebo | Total |
|---|---|---|---|
| Female | 37 | 36 | 73 |
| Male | 3 | 4 | 7 |
| Region of Enrollment(participants) | Barley Beta-glucan(3.0g) | Placebo | Total |
|---|---|---|---|
| Korea, Republic of | 40 | 40 | 80 |
The record gives a start of Jun 2010, a primary completion of Oct 2010 and a completion of May 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2012, 2 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chonbuk National University Hospital