Fuctional Assessment of Kefir Fermented Milk on the Improvement of Osteoporosis Combined With Fracture Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiographic Healing Score at 3 Months
研究概览
简要总结
This study is designed to evaluate the effects of kefir-derived peptides on bone healing in patients with upper limb fractures. Kefir peptides are natural protein fragments that may promote bone formation and reduce inflammation. Participants with recent upper limb fractures will be randomly assigned to receive either kefir peptide supplementation or standard treatment. The main purpose of this study is to determine whether kefir peptides can accelerate bone healing and improve recovery compared to standard care.
详细描述
This study aims to investigate the efficacy of kefir-derived peptides in enhancing bone healing after upper limb fractures. Kefir peptides are bioactive fragments of milk proteins that have shown potential in stimulating osteoblast differentiation, inhibiting osteoclast activity, and modulating inflammation in preclinical studies.
The study is designed as a randomized, controlled clinical trial. Eligible participants with acute upper limb fractures will be randomly assigned to receive either kefir peptide supplementation in addition to standard care, or standard care alone. The primary objective is to evaluate radiographic and clinical healing at 6 months, while secondary outcomes include pain relief, functional recovery, and quality of life measures.
This trial seeks to provide clinical evidence supporting kefir peptides as a safe and natural adjunct therapy to accelerate bone repair, potentially reducing recovery time and improving functional outcomes for patients with fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and care providers are blinded to treatment assignment. The kefir peptide supplement and placebo are identical in appearance and packaging.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone mineral density T-score ≤ -2.5 measured by dual-energy X-ray absorptiometry (DXA)
- •Acute fragility fracture of the distal radius or proximal humerus, and
- •Postmenopausal women
- •Age ≥ 50 years
排除标准
- •Body mass index (BMI) > 30 kg/m²
- •Use of medications affecting bone metabolism for more than 4 months, including: glucocorticoids、thyroxine、antiepileptic drugs、bisphosphonates
- •calcitonin、hormone replacement therapy
- •History of metabolic or systemic diseases affecting bone metabolism, including: hyperparathyroidism、hyperthyroidism、diabetes mellitus、 hepatic cirrhosis、renal insufficiency
结局指标
主要结局
Radiographic Healing Score at 3 Months
时间窗: 3 months after fracture fixation
Bone healing will be assessed using standard radiographs and the modified Lane and Sandhu scoring system.
次要结局
未报告次要终点
研究者
Jen-Chieh Lai
Taichung Armed Forces General Hospital
National Chung Hsing University