Kefir Peptides for Bone Fracture Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2025-04-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bone Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants and care providers are blinded to treatment assignment. The kefir peptide supplement and placebo are identical in appearance and packaging.

Study Groups

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Kefir Peptide + Standard Care

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

Group Type EXPERIMENTAL

Kefir Peptide

Intervention Type DIETARY_SUPPLEMENT

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

Standard Care

Participants will receive standard fracture care without kefir peptide supplementation.

Group Type ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type OTHER

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

Interventions

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Kefir Peptide

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

Intervention Type DIETARY_SUPPLEMENT

Standard Care (in control arm)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No