- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402115
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Jeollabuk-do
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Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
- Healthcare claims and management; Chonbuk National university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polycan
Polycan 150mg for 12 weeks
|
polycan 150 mg/d for 12 weeks
|
Placebo Comparator: Placebo
Placebo 15mg for 12 weeks
|
Placebo 150mg/d for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in DPD(Deoxypyridinoline)
Time Frame: 12weeks
|
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
|
12weeks
|
Changes in OSC(Osteocalcin)
Time Frame: 12weeks
|
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
Time Frame: 12weeks
|
CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).
|
12weeks
|
Changes in bALP(Bone-specific Alkaline Phosphatase)
Time Frame: 12weeks
|
bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
|
12weeks
|
Changes in PTH(Parathyroid Hormone)
Time Frame: 12weeks
|
PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).
|
12weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dal-Sik Kim, MD, Chonbuk National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Glu-POLYCAN-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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