Efficacy and Safety Study of Polycan on Bone Metabolism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in DPD(Deoxypyridinoline)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).
- •Perimenopausal women : aged 40-70
排除标准
- •Women with a body mass index (BMI) >30 kg/m2 or who were being treated with estrogens, corticosteroids, or bisphosphonates, or who had significant illness affecting bone metabolism were excluded
结局指标
主要结局
Changes in DPD(Deoxypyridinoline)
时间窗: 12weeks
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin)
时间窗: 12weeks
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)(12weeks)
- Changes in bALP(Bone-specific Alkaline Phosphatase)(12weeks)
- Changes in PTH(Parathyroid Hormone)(12weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital