Bone Health in Perimenopausal WomenPhase 2/3NCT01402115
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
A Phase 2/3 study testing Polycan in people with Bone Health in Perimenopausal Women, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Health in Perimenopausal Women
- What is being tested?
- Polycan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to May 2009
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).
- Perimenopausal women : aged 40-70
Who cannot join
- Women with a body mass index (BMI) >30 kg/m2 or who were being treated with estrogens, corticosteroids, or bisphosphonates, or who had significant illness affecting bone metabolism were excluded
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Healthcare claims and management; Chonbuk National university
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: Efficacy and Safety Study of Polycan on Bone Metabolism
Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing effects. However, no investigation has been conducted on the effect of polycan on bone health in perimenopausal women.
Therefore, in this study, we investigated the effect of polycan on biochemical markers of bone metabolism in Korean perimenopausal women.
- Conditions
- Bone Health in Perimenopausal Women
- Being tested
- Polycan, Placebo
- Keywords
- Polycan, Bone metabolism, Osteocalcin, Deoxypyridinoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolycanDietary supplement
polycan 150 mg/d for 12 weeks
PlaceboDietary supplement
Placebo 150mg/d for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polycan | Experimental | Polycan 150mg for 12 weeks Receives: Dietary Supplement: Polycan |
| Placebo | Placebo comparator | Placebo 15mg 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 DPD(Deoxypyridinoline)
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12weeks
Changes in OSC(Osteocalcin)
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12weeks
Secondary outcomes (3)
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12weeks
Changes in bALP(Bone-specific Alkaline Phosphatase)
bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12weeks
Changes in PTH(Parathyroid Hormone)
PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12weeks
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 startNov 2008
- Primary completionFeb 2009
- Study completionMay 2009
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 Bone Health in Perimenopausal WomenStudies 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
- 60 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
- Dal-Sik Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402115
- Sponsor's protocol ID
- Glu-POLYCAN-001
- Status last verified
- Oct 2012
- First submitted
- 21 Jul 2011
- Last updated
- 12 Oct 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 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Polycan on Bone Metabolism
- ClinicalTrials.gov ID
- NCT01402115
- Acronym / sponsor ID
- Glu-POLYCAN-001
- Conditions
- Bone Health in Perimenopausal Women
- Keywords
- Polycan, Bone metabolism, Osteocalcin, Deoxypyridinoline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Posted 5 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing effects. However, no investigation has been conducted on the effect of polycan on bone health in perimenopausal women.
Therefore, in this study, we investigated the effect of polycan on biochemical markers of bone metabolism in Korean perimenopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycan | Experimental | Dietary Supplement: PolycanPolycan 150mg for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 15mg for 12 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).
- Perimenopausal women : aged 40-70
Key exclusion criteria (1 listed)
- Women with a body mass index (BMI) >30 kg/m2 or who were being treated with estrogens, corticosteroids, or bisphosphonates, or who had significant illness affecting bone metabolism were excluded
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 |
|---|---|---|
| Polycanpolycan 150 mg/d for 12 weeks | Dietary supplement | Polycan |
| PlaceboPlacebo 150mg/d for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes in DPD(Deoxypyridinoline)
Time frame: 12weeks
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin)
Time frame: 12weeks
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
3 secondary outcomes
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
Time frame: 12weeks
Changes in bALP(Bone-specific Alkaline Phosphatase)
Time frame: 12weeks
Changes in PTH(Parathyroid Hormone)
Time frame: 12weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bone Health in Perimenopausal Women
Enrolling by invitationObservational study
Multidimensional Determinants of Functional Health In Women Aged 45-60
Healthy, Perimenopausal Depression
Not yet recruiting
Calcium-Rich Food Versus Calcium Carbonate for Bone Health
Osteopenia, Osteoporosis
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.
Dal-Sik Kim, MD 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 Polycan in people with Bone Health in Perimenopausal Women, 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 2 inclusion and 1 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 12 Oct 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 5 Oct 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 DPD(Deoxypyridinoline) (time frame: 12weeks). 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 12 Oct 2012.