Overweight; HyperlipidemiaPhase 2/3NCT01402128
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
A Phase 2/3 study testing Barley beta-glucan(3.0g) in people with Overweight; Hyperlipidemia, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight; Hyperlipidemia
- What is being tested?
- Barley beta-glucan(3.0g)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to May 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: The Effect of Barley Beta-glucan on Serum Lipids and Body Weight
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.
Read the 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.
- Conditions
- Overweight; Hyperlipidemia
- Being tested
- Barley beta-glucan(3.0g), Placebo
- Keywords
- Soluble fiber, Polycan, Overweight, LDL-C(Low Density Lipoprotein-cholesterol)
- Medical subject headings
- Overweight, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barley beta-glucan(3.0g)Dietary supplement
Barley beta-glucan(3.0g/day) for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Barley beta-glucan(3.0g) | Experimental | Barley beta-glucan(3.0g/day) for 12 weeks Receives: Dietary Supplement: Barley beta-glucan(3.0g) |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Fat Mass(kg)
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in Percent Body Fat(%)
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Secondary outcomes (9)
Changes in Visceral Adipose Tissue
Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in Triglyceride
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Changes in Subcutaneous Adipose Tissue
Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight; HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Soo-Wan Chae, MD., PhD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402128
- Sponsor's protocol ID
- MTB-bG-001
- Status last verified
- Nov 2012
- First submitted
- 21 Jul 2011
- Last updated
- 25 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Barley Beta-glucan on Serum Lipids and Body Weight
- ClinicalTrials.gov ID
- NCT01402128
- Acronym / sponsor ID
- MTB-bG-001
- Conditions
- Overweight; Hyperlipidemia
- Keywords
- Soluble fiber, Polycan, Overweight, LDL-C(Low Density Lipoprotein-cholesterol)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Posted 25 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barley beta-glucan(3.0g) | Experimental | Dietary Supplement: Barley beta-glucan(3.0g)Barley beta-glucan(3.0g/day) for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barley beta-glucan(3.0g)Barley beta-glucan(3.0g/day) for 12 weeks | Dietary supplement | Barley beta-glucan(3.0g) |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes in Body Fat Mass(kg)
Time frame: 12 weeks
Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat(%)
Time frame: 12 weeks
Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).
9 secondary outcomes
Changes in Visceral Adipose Tissue
Time frame: 12 weeks
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
Time frame: 12 weeks
Changes in HDL-C(High Density Lipoprotein-cholesterol)
Time frame: 12 weeks
Changes in Total Cholesterol
Time frame: 12 weeks
Changes in Triglyceride
Time frame: 12 weeks
Changes in FFA(Free Fatty Acid)
Time frame: 12 weeks
Changes in Apo-A1(Apolipoprotein A1)
Time frame: 12 weeks
Changes in Apo-B(Apolipoprotein B)
Time frame: 12 weeks
Changes in Subcutaneous Adipose Tissue
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo-Wan Chae, MD., PhD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Barley beta-glucan(3.0g) in people with Overweight; Hyperlipidemia, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Fat Mass(kg) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2012.