A 12-week Human Trial to Compare the Efficacy and Safety 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.
|Bone Health in Perimenopausal Women||Dietary Supplement: Polycan Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Efficacy and Safety Study of Polycan on Bone Metabolism|
- 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).
|Study Start Date:||November 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|