HealthyNCT05117437
The Effect Of Anaerobic Exercise On Bone Morphogenetic Protein 9
An observational study of Healthy and Exercise, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Bone morphogenetic protein (BMP) 9 from the BMP family has an important role in the remodeling of bone and cartilage. Due to these features, BMP9 can play an important role in especially anaerobic exercise training adaptations. However, the role of anaerobic exercise in these effects is still unclear. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- What is being tested?
- Physiological test, Physical test and Biochemical tests
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2020to 1 Dec 2021
- Phase
- Observational
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Athletic group: trained male athletes who did anaerobic sports (such as basketball, volleyball and handball) Control group: sedentary males
Who may be able to join
- being male
- having a body mass index of less than 30 being
Who cannot join
- to have some disease or disability
- to regularly use cigarettes and alcohol
- to use any medication or antioxidant substance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Sport Sciences
Izmir, 35040
About this study
Bone morphogenetic protein (BMP) 9 from the BMP family has an important role in the remodeling of bone and cartilage. Due to these features, BMP9 can play an important role in especially anaerobic exercise training adaptations. However, the role of anaerobic exercise in these effects is still unclear. The aim of this study is to investigate the role of BMP9 on the effects of acute and chronic anaerobic exercise on bone metabolism markers. Postprandial venous blood samples were taken pre- and post- acute YOYO intermittent recovery test (level 1) in 40 trained male athletes aged 18-35 who did anaerobic sports (such as basketball, volleyball and handball) and 41 sedentary volunteers aged 18-35. Serum BMP9, as markers of bone formation and resorption; alkaline phosphatase (ALP), C-terminal telopeptide of type 1 collagen (CTX1), cartilage oligomeric matrix protein (COMP) and calcium levels were determined. The data to be obtained as a result of our study can give information about the relationship between the skeletal and bone health of the athletes and anaerobic exercise.
- Being tested
- Physiological test, Physical test, Biochemical tests
- Keywords
- Bone morphogenetic protein, BMP9, anaerobic exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological testOther
Also called YOYO intermittent recovery test (level 1)
This test was conducted to determine the endurance levels of the participants.
Physical testOther
Height, weight, and BMI were determined
Biochemical testsOther
BMP9, CTX1, COMP, oxLDL protein levels, ALP, GGT, TAS, TOS, OSI, NO, calcium, T-C, LDL-C, Triglyceride, HDL-C, glucose, CRP, AST, ALT, erythrocyte, mean erythrocyte volume (MCV), hematocrit, leukocyte, thrombocyte levels were determined from blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Athletic group | Healthy male athletes who have been doing regular anaerobic sports (such as basketball, volleyball and handball) for at least 3 months Receives: Other: Physiological test; Other: Physical test; Other: Biochemical tests | |
| Control group | Healthy sedentary (not doing regular sports for at least 3 months) men with age and physical characteristics similar to the athlete group Receives: Other: Physiological test; Other: Physical test; Other: Biochemical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from serum BMP9 levels at pre- and post- YOYO intermittent test
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum Bone morphogenetic protein 9 (BMP9) was determined.
Measured: between 40-50 minutes
Change from serum CTX1 levels at pre- and post- YOYO intermittent test
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum C-terminal telopeptide of Type 1 collagen (CTX1) was determined.
Measured: between 40-50 minutes
Change from serum COMP levels at pre- and post- YOYO intermittent test
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum cartilage oligomeric matrix protein (COMP) was determined.
Measured: between 40-50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start3 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Turgay, Ege University
- Investigators
- Faruk Turgay, Study director, Ege University Faculty of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117437
- Sponsor's protocol ID
- TDK-2020-22186
- Other IDs
- TDK-2020-22186
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2021
- Last updated
- 11 Nov 2021
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Anaerobic Exercise On Bone Morphogenetic Protein 9
- ClinicalTrials.gov ID
- NCT05117437
- Acronym / sponsor ID
- TDK-2020-22186
- Keywords
- Bone morphogenetic protein, BMP9, anaerobic exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Nov 2021 (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.
Bone morphogenetic protein (BMP) 9 from the BMP family has an important role in the remodeling of bone and cartilage. Due to these features, BMP9 can play an important role in especially anaerobic exercise training adaptations. However, the role of anaerobic exercise in these effects is still unclear. The aim of this study is to investigate the role of BMP9 on the effects of acute and chronic anaerobic exercise on bone metabolism markers. Postprandial venous blood samples were taken pre- and post- acute YOYO intermittent recovery test (level 1) in 40 trained male athletes aged 18-35 who did anaerobic sports (such as basketball, volleyball and handball) and 41 sedentary volunteers aged 18-35. Serum BMP9, as markers of bone formation and resorption; alkaline phosphatase (ALP), C-terminal telopeptide of type 1 collagen (CTX1), cartilage oligomeric matrix protein (COMP) and calcium levels were determined. The data to be obtained as a result of our study can give information about the relationship between the skeletal and bone health of the athletes and anaerobic exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletic group | – | Other: Physiological test, Other: Physical test, Other: Biochemical testsHealthy male athletes who have been doing regular anaerobic sports (such as basketball, volleyball and handball) for at least 3 months |
| Control group | – | Other: Physiological test, Other: Physical test, Other: Biochemical testsHealthy sedentary (not doing regular sports for at least 3 months) men with age and physical characteristics similar to the athlete group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Athletic group: trained male athletes who did anaerobic sports (such as basketball, volleyball and handball) Control group: sedentary males
Key inclusion criteria (2 listed)
- being male
- having a body mass index of less than 30 being
Key exclusion criteria (3 listed)
- to have some disease or disability
- to regularly use cigarettes and alcohol
- to use any medication or antioxidant substance
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 |
|---|---|---|
| Physiological testAlso: YOYO intermittent recovery test (level 1)This test was conducted to determine the endurance levels of the participants. | Other | Athletic group, Control group |
| Physical testHeight, weight, and BMI were determined | Other | Athletic group, Control group |
| Biochemical testsBMP9, CTX1, COMP, oxLDL protein levels, ALP, GGT, TAS, TOS, OSI, NO, calcium, T-C, LDL-C, Triglyceride, HDL-C, glucose, CRP, AST, ALT, erythrocyte, mean erythrocyte volume (MCV), hematocrit, leukocyte, thrombocyte levels were determined from blood samples. | Other | Athletic group, Control group |
Primary outcome
Change from serum BMP9 levels at pre- and post- YOYO intermittent test
Time frame: between 40-50 minutes
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum Bone morphogenetic protein 9 (BMP9) was determined.
Change from serum CTX1 levels at pre- and post- YOYO intermittent test
Time frame: between 40-50 minutes
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum C-terminal telopeptide of Type 1 collagen (CTX1) was determined.
Change from serum COMP levels at pre- and post- YOYO intermittent test
Time frame: between 40-50 minutes
Postprandial venous blood samples were obtained before and after acute YOYO IR test (level 1). The YOYO test lasted 10-20 minutes depending on the ability level of the participants. A blood sample was taken 15 minutes before and 15 minutes after the YOYO test. From these blood samples, serum cartilage oligomeric matrix protein (COMP) was determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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.
Faruk Turgay study director
Ege University Faculty of Sport Sciences
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 Healthy and Exercise, run by Ege University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Change from serum BMP9 levels at pre- and post- YOYO intermittent test (time frame: between 40-50 minutes). The study lists 3 primary outcomes in all. 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 11 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.