Randomized, Double-blind, Placebo-controlled Trial of the Effects of Polycan, β-glucan Originating from Aureobasidium Pullulans, on Bone Biomarkers in Healthy Women
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 perimenopau...
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Published in | Korean Journal of Oriental Physiology & Pathology Vol. 29; no. 4; pp. 330 - 336 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
한의병리학회
31.08.2015
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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. KCI Citation Count: 0 |
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AbstractList | 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 |
Author | In Soon Choi Soo-Jin Park Jae Suk Choi Mi Yeon Park Ki Young Kim Jong Dae Kim Joo Wan Kim Hyung Rae Cho Sae Kwang Ku |
Author_xml | – sequence: 1 givenname: Jong Dae surname: Kim fullname: Kim, Jong Dae – sequence: 2 givenname: Mi Yeon surname: Park fullname: Park, Mi Yeon – sequence: 3 givenname: Joo Wan surname: Kim fullname: Kim, Joo Wan – sequence: 4 givenname: Ki Young surname: Kim fullname: Kim, Ki Young – sequence: 5 givenname: Hyung Rae surname: Cho fullname: Cho, Hyung Rae – sequence: 6 givenname: In Soon surname: Choi fullname: Choi, In Soon – sequence: 7 givenname: Jae Suk surname: Choi fullname: Choi, Jae Suk – sequence: 8 givenname: Sae Kwang surname: Ku fullname: Ku, Sae Kwang – sequence: 9 givenname: Soo-Jin surname: Park fullname: Park, Soo-Jin |
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Title | 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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