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http://dx.doi.org/10.15188/kjopp.2015.08.29.4.330

Randomized, Double-blind, Placebo-controlled Trial of the Effects of Polycan, β-glucan Originating from Aureobasidium Pullulans, on Bone Biomarkers in Healthy Women  

Kim, Jong Dae (Department of Internal Medicine, College of Korean Medicine, Daegu Haany University)
Park, Mi Yeon (Department of Internal Medicine, College of Korean Medicine, Daegu Haany University)
Kim, Joo Wan (Glucan Corporation Research Institute, Techno Park Marine Bio-industry Development Center)
Kim, Ki Young (Glucan Corporation Research Institute, Techno Park Marine Bio-industry Development Center)
Cho, Hyung Rae (Glucan Corporation Research Institute, Techno Park Marine Bio-industry Development Center)
Choi, In Soon (Department of Biological Science, Silla University)
Choi, Jae Suk (RIS Center, Industry-Academic Cooperation Foundation, Silla University)
Ku, Sae Kwang (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University)
Park, Soo-Jin (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University)
Publication Information
Journal of Physiology & Pathology in Korean Medicine / v.29, no.4, 2015 , pp. 330-336 More about this Journal
Abstract
Polycan originating from Aureobasidium pullulans is mostly composed of β-1, 3/1, 6 glucans and possesses an anti-osteoporotic effect. We conducted a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of the polycan on bone biochemical markers in healthy perimenopausal women. Sixty subjects were randomly allocated to 2 groups-group 1 received 400 mg of polycan and group 2 received placebo-these were administered once daily for 28 days. Fasting blood and urine samples were collected at baseline and 4 weeks after treatment. The primary outcome was change in osteocalcin (OSC) and bone-specific alkaline phosphatase (BALP). Changes in calcium (Ca), phosphorus (P), C-telopeptide of collagen cross-links (CTx), N-telopeptide of collagen cross-links (NTx), and deoxypyridinoline (DPYR) were the secondary outcomes. A safety assessment was performed using adverse event (AE) and laboratory data. After 4 weeks of polycan treatment, OSC, DPYR, and BALP levels changed (P < 0.05) significantly from baseline in both groups. However, no significant differences were observed in any markers between the 2 groups, except for P (P < 0.05). Interestingly, group 2 showed a significant increase in CTx (65.2%, P < 0.05), while CTx in group 1 slightly increased (17.2%). Both groups showed no significant differences in AE. Although 4 weeks of polycan treatment did not have a statistically significant effect on bone metabolism biomarkers, increases in CTx were modestly inhibited by polycan. Further studies in a large population and longer treatment periods are needed to confirm the effect of polycan on bone turnover.
Keywords
β-glucans; Polycan; Bone turnover; Osteoporosis; Bone biomarker;
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