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

• Published in: Korean Journal of Oriental Physiology & Pathology Vol. 29; no. 4; pp. 330 - 336
• Main Authors: Kim, Jong Dae, Park, Mi Yeon, Kim, Joo Wan, Kim, Ki Young, Cho, Hyung Rae, Choi, In Soon, Choi, Jae Suk, Ku, Sae Kwang, Park, Soo-Jin
• Format: Journal Article
• Language: English
• Published: 한의병리학회 31.08.2015
• Subjects: 한의학; Osteoporosis; Polycan; β-glucans; Bone turnover; Bone biomarker
• ISSN: 1738-7698; 2288-2529
• DOI: 10.15188/kjopp.2015.08.29.4.330

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. KCI Citation Count: 0