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KMID : 1123920150290040330
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Korean Journal of Oriental Physiology and Pathology
2015 Volume.29 No. 4 p.330 ~ p.336
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Randomized, Double-blind, Placebo-controlled Trial of the Effects of Polycan, β-glucan Originating from Aureobasidium Pullulans, on Bone Biomarkers in Healthy Women
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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
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Abstract
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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.
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KEYWORD
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β-glucans, Polycan, Bone turnover, Osteoporosis, Bone biomarker
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