Bone Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTKefir Peptide
Oral supplementation with kefir-derived bioactive peptides given daily in addition to standard care.
OTHERStandard Care (in control arm)
Standard fracture management including immobilization, pain control, and routine follow-up care.
Sponsors
Jen-Chieh Lai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and care providers are blinded to treatment assignment. The kefir peptide supplement and placebo are identical in appearance and packaging.
Intervention model description
Participants will be randomly assigned to two parallel groups: one group receiving kefir peptide supplementation plus standard care, and the other group receiving standard care alone.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Bone mineral density T-score ≤ -2.5 measured by dual-energy X-ray absorptiometry (DXA) 2. Acute fragility fracture of the distal radius or proximal humerus, and 3. Postmenopausal women 4. Age ≥ 50 years
Exclusion criteria
1. Body mass index (BMI) \> 30 kg/m² 2. Use of medications affecting bone metabolism for more than 4 months, including: glucocorticoids、thyroxine、antiepileptic drugs、bisphosphonates * calcitonin、hormone replacement therapy 3. History of metabolic or systemic diseases affecting bone metabolism, including: hyperparathyroidism、hyperthyroidism、diabetes mellitus、 hepatic cirrhosis、renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Healing Score at 3 Months | 3 months after fracture fixation | Bone healing will be assessed using standard radiographs and the modified Lane and Sandhu scoring system. |
Countries
Taiwan
Outcome results
None listed