Sports MedicineNCT06888635
Predicting the Metabolic Biomarkers Associated With Injury in Athletes
An observational study of Sports Medicine, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
For elite athletes, sports injuries significantly impede the further enhancement of their competitive performance. Consequently, the significance of preventing, detecting, and addressing potential injury issues has become increasingly critical. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Medicine
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include: 1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage. 2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction. 3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising. 4. Fracture: The bone is broken due to external force. 5. Dislocation: The joint is removed from its normal position due to external forces.
Who may be able to join
- Age： Athletes 12-30 years old
- Acute injury during exercise: such as muscle, sprain, contusion, torn ligament, dislocation, fracture.
Who cannot join
- Athletes with serious cardio-cerebrovascular disease and abnormal liver and kidney function
- Recent use of drugs or supplements that affect metabolism.
- Pregnancy, lactation or special conditions that may affect metabolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Respiratory, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,China
Shanghai, 200092
About this study
For elite athletes, sports injuries significantly impede the further enhancement of their competitive performance. Consequently, the significance of preventing, detecting, and addressing potential injury issues has become increasingly critical. Currently, the comprehensive evaluation of athletes' physical function and condition primarily depends on a range of physiological, biochemical, and immunological indicators. However, these methods have progressively exposed their limitations. As an advanced bioinformatics technology, omics research demonstrates unique advantages. By leveraging multi-omics research and analysis, it is possible to more accurately observe the physiological and biochemical changes that athletes undergo during training and competition, as well as their regulatory mechanisms. This approach can provide practical data, identify biomarkers that can warn of potential injuries, and offer precise guidance for training monitoring and injury prevention. It also provides a foundation for developing diverse, precise, and personalized sports programs and rehabilitation plans.
Read the detailed description
Investigators will collect fasting venous blood. White blood cell count, red blood cell count, erythrocyte specific volume, hemoglobin, C-reactive protein, procalcitonin, erythrocyte sediment rate, lactic acid,creatine kinase, liver function indicators, blood urea, blood creatinine, blood uric acid, blood testosterone, blood cortisol, immunoglobulin (IgG, IgA, IgM) and ferritin levels were measured. The levels of IL-2, IL-6, IL-1β and TNF-α were determined by ELISA. Blood samples were purified and analyzed by proteomics, metabolomics and lipidomics methods. Urine and stool samples were collected and analyzed by multi-omics method.
- Conditions
- Sports Medicine
- Keywords
- sports medicine,, injury, biomarker, metabolite
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Injury athletes | Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include: 1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage. 2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction. 3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising. 4. Fracture: The bone is broken due to external force. 5. Dislocation: The joint is removed from its normal position due to external forces. | |
| Healthy athletes | athletes with no acute injury in the last 3 months | |
| Healthy | Healthy non-athlete population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with athletes with acute injuries
Acute injuries are defined as the injuries of body tissues in a short period of time due to sudden external force or improper operation during sports.This injury usually has sudden and distinct traumatic features
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start16 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports MedicineStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Zhang, Doctor, Principal investigator, Department of Respiratory, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888635
- Sponsor's protocol ID
- XH-25-003
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Metabolic Biomarkers Associated With Injury in Athletes
- ClinicalTrials.gov ID
- NCT06888635
- Acronym / sponsor ID
- XH-25-003
- Conditions
- Sports Medicine
- Keywords
- sports medicine,, injury, biomarker, metabolite
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Mar 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.
For elite athletes, sports injuries significantly impede the further enhancement of their competitive performance. Consequently, the significance of preventing, detecting, and addressing potential injury issues has become increasingly critical. Currently, the comprehensive evaluation of athletes' physical function and condition primarily depends on a range of physiological, biochemical, and immunological indicators. However, these methods have progressively exposed their limitations. As an advanced bioinformatics technology, omics research demonstrates unique advantages. By leveraging multi-omics research and analysis, it is possible to more accurately observe the physiological and biochemical changes that athletes undergo during training and competition, as well as their regulatory mechanisms. This approach can provide practical data, identify biomarkers that can warn of potential injuries, and offer precise guidance for training monitoring and injury prevention. It also provides a foundation for developing diverse, precise, and personalized sports programs and rehabilitation plans.
Detailed description
Investigators will collect fasting venous blood. White blood cell count, red blood cell count, erythrocyte specific volume, hemoglobin, C-reactive protein, procalcitonin, erythrocyte sediment rate, lactic acid,creatine kinase, liver function indicators, blood urea, blood creatinine, blood uric acid, blood testosterone, blood cortisol, immunoglobulin (IgG, IgA, IgM) and ferritin levels were measured. The levels of IL-2, IL-6, IL-1β and TNF-α were determined by ELISA. Blood samples were purified and analyzed by proteomics, metabolomics and lipidomics methods. Urine and stool samples were collected and analyzed by multi-omics method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Injury athletes | – | –Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include: 1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage. 2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction. 3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising. 4. Fracture: The bone is broken due to external force. 5. Dislocation: The joint is removed from its normal position due to external forces. |
| Healthy athletes | – | –athletes with no acute injury in the last 3 months |
| Healthy | – | –Healthy non-athlete population |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include: 1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage. 2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction. 3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising. 4. Fracture: The bone is broken due to external force. 5. Dislocation: The joint is removed from its normal position due to external forces.
Key inclusion criteria (2 listed)
- Age： Athletes 12-30 years old
- Acute injury during exercise: such as muscle, sprain, contusion, torn ligament, dislocation, fracture.
Key exclusion criteria (3 listed)
- Athletes with serious cardio-cerebrovascular disease and abnormal liver and kidney function
- Recent use of drugs or supplements that affect metabolism.
- Pregnancy, lactation or special conditions that may affect metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with athletes with acute injuries
Time frame: 1year
Acute injuries are defined as the injuries of body tissues in a short period of time due to sudden external force or improper operation during sports.This injury usually has sudden and distinct traumatic features
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
Yue Zhang, Doctor principal investigator
Department of Respiratory, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Medicine, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with athletes with acute injuries (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.