NCT07166458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

September 2, 2025

Last Update Submit

March 22, 2026

Conditions

Bone Fractures

Outcome Measures

Primary Outcomes (1)

  • Radiographic Healing Score at 3 Months

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

    3 months after fracture fixation

Study Arms (2)

Kefir Peptide + Standard Care

EXPERIMENTAL

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

Dietary Supplement: Kefir Peptide

Standard Care

ACTIVE COMPARATOR

Participants will receive standard fracture care without kefir peptide supplementation.

Other: Standard Care (in control arm)

Interventions

Kefir PeptideDIETARY_SUPPLEMENT

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

Kefir Peptide + Standard Care
Standard Care (in control arm)OTHER

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

Standard Care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Chung Hsing University

Taichung, Taiwan

Location

Related Publications (2)

  • Lai JC, Chang GR, Tu MY, Cidem A, Chen IC, Chen CM. Potential of Kefir-Derived Peptides, Probiotics, and Exopolysaccharides for Osteoporosis Management. Curr Osteoporos Rep. 2025 Apr 7;23(1):18. doi: 10.1007/s11914-025-00910-9.

    PMID: 40192921RESULT

  • Lai JC, Li HP, Chang GR, Lan YW, Chen YH, Tseng YS, Tu MY, Chen CF, Chen HL, Chen CM. Kefir peptides promote osteogenic differentiation to enhance bone fracture healing in rats. Life Sci. 2022 Dec 1;310:121090. doi: 10.1016/j.lfs.2022.121090. Epub 2022 Oct 17.

    PMID: 36257457RESULT

Related Links

MeSH Terms

Conditions

Fractures, Bone

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and care providers are blinded to treatment assignment. The kefir peptide supplement and placebo are identical in appearance and packaging.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Taichung Armed Forces General Hospital

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 10, 2025

Study Start

April 13, 2020

Primary Completion

July 20, 2024

Study Completion

April 20, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)