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Completed

NCT Number: NCT07166458

Kefir Peptides for Bone Fracture Healing

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Chung Hsing University

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Kefir Peptide

Dietary Supplement

Oral supplementation with kefir-derived bioactive peptides given daily in addition to standard care.

Standard Care (in control arm)

Other

Standard fracture management including immobilization, pain control, and routine follow-up care.

Primary outcomes

  1. Radiographic Healing Score at 3 Months

    Time frame: 3 months after fracture fixation

    Bone healing will be assessed using standard radiographs and the modified Lane and Sandhu scoring system.

Sponsors and collaborators

Lead sponsor

Jen-Chieh Lai

Other

Registry information

Official study title

Fuctional Assessment of Kefir Fermented Milk on the Improvement of Osteoporosis Combined With Fracture Patient

Acronym: KPs-Fracture

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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