Bone FracturesKPs-FractureNCT07166458
Kefir Peptides for Bone Fracture Healing
A study testing Kefir Peptide in people with Bone Fractures, run by Jen-Chieh Lai at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Kefir Peptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Apr 2020to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fuctional Assessment of Kefir Fermented Milk on the Improvement of Osteoporosis Combined With Fracture Patient
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.
Read the 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.
- Conditions
- Bone Fractures
- Being tested
- Kefir Peptide, Standard Care (in control arm)
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kefir PeptideDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Kefir Peptide + Standard Care | Experimental | Participants will receive kefir peptide supplementation in addition to standard fracture care. Receives: Dietary Supplement: Kefir Peptide |
| Standard Care | Active comparator | Participants will receive standard fracture care without kefir peptide supplementation. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Healing Score at 3 Months
Bone healing will be assessed using standard radiographs and the modified Lane and Sandhu scoring system.
Measured: 3 months after fracture fixation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start13 Apr 2020
- Primary completion20 Jul 2024
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jen-Chieh Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jen-Chieh Lai, National Chung Hsing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166458
- Sponsor's protocol ID
- B202005023
- Acronym
- KPs-Fracture
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40192921Lai 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.
PubMed 36257457
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuctional Assessment of Kefir Fermented Milk on the Improvement of Osteoporosis Combined With Fracture Patient
- ClinicalTrials.gov ID
- NCT07166458
- Acronym / sponsor ID
- KPs-Fracture / B202005023
- Conditions
- Bone Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jen-Chieh LaiUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kefir Peptide + Standard Care | Experimental | Dietary Supplement: Kefir PeptideParticipants will receive kefir peptide supplementation in addition to standard fracture care. |
| Standard Care | Active comparator | Other: Standard Care (in control arm)Participants will receive standard fracture care without kefir peptide supplementation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Body mass index (BMI) > 30 kg/m²
- Use of medications affecting bone metabolism for more than 4 months, including: glucocorticoids、thyroxine、antiepileptic drugs、bisphosphonates
- History of metabolic or systemic diseases affecting bone metabolism, including: hyperparathyroidism、hyperthyroidism、diabetes mellitus、 hepatic cirrhosis、renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kefir PeptideOral supplementation with kefir-derived bioactive peptides given daily in addition to standard care. | Dietary supplement | Kefir Peptide + Standard Care |
| Standard Care (in control arm)Standard fracture management including immobilization, pain control, and routine follow-up care. | Other | Standard Care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 40192921Lai 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.
- Results publication: PubMed 36257457Lai 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kefir Peptide in people with Bone Fractures, run by Jen-Chieh Lai at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Healing Score at 3 Months (time frame: 3 months after fracture fixation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07166458, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.