Kefir Peptides for Bone Fracture Healing (KPs-Fracture)

Jen-Chieh Lai

Status: Completed

Conditions: Bone Fractures

Treatments: Other: Standard Care (in control arm); Dietary Supplement: Kefir Peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT07166458

B202005023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) patients with a bone mineral density T-score determined by dual energy X-ray absorptiometry (DXA) < -2.5 or patients with acute fragile fractures in the distal radius and proximal humerus, and additionally (2) women with menopause or (3) patients who are over 50 years of age.

Exclusion criteria

• (1) a body mass index (BMI) > 30, (2) those who have been administered pharmacological agents such as glucocorticoids, thyroxine, antiepileptics, bisphosphonates, calcitonin, and hormone replacement therapy, or medications impacting bone metabolism for a duration over 4 months, and (3) individuals with a documented medical history of hyperparathyroidism, hyperthyroidism, diabetes mellitus, hepatic cirrhosis, and renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Kefir Peptide + Standard Care

Experimental group

Description:

Participants will receive kefir peptide supplementation in addition to standard fracture care.

Treatment:

Dietary Supplement: Kefir Peptide

Standard Care

Active Comparator group

Description:

Participants will receive standard fracture care without kefir peptide supplementation.

Treatment:

Other: Standard Care (in control arm)