A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
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|ClinicalTrials.gov Identifier: NCT01402115|
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : October 5, 2012
Last Update Posted : October 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Health in Perimenopausal Women||Dietary Supplement: Polycan Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy and Safety Study of Polycan on Bone Metabolism|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||May 2009|
Polycan 150mg for 12 weeks
Dietary Supplement: Polycan
polycan 150 mg/d for 12 weeks
Placebo Comparator: Placebo
Placebo 15mg for 12 weeks
Dietary Supplement: Placebo
Placebo 150mg/d for 12 weeks
- 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).
- 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).
- 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).
- Changes in PTH(Parathyroid Hormone) [ Time Frame: 12weeks ]PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402115
|Korea, Republic of|
|Healthcare claims and management; Chonbuk National university|
|Jeonju, Jeollabuk-do, Korea, Republic of, 560-822|
|Principal Investigator:||Dal-Sik Kim, MD||Chonbuk National University Hospital|