To Determine the Levels of miRNA1 and miRNA133a Before and After ExerciseNCT06083610
MicroRNA-1 (miRNA-1) and MicroRNA-133a (miRNA-133a) Levels After Acute Exercise in Ultimate Frisbee Athletes
An observational study of To Determine the Levels of miRNA1 and miRNA133a Before and After Exercise, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
"The goal of this clinical trial is to investigate the levels of microRNA-1 (miRNA-1) and microRNA-133a (miRNA-133a) after acute neuromuscular exercise (NME) in human saliva. The main questions it aims to answer are: How do miRNA-1 and miRNA-133a levels change in response to acute neuromuscular exercise in human… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- To Determine the Levels of miRNA1 and miRNA133a Before and After Exercise
- What is being tested?
- miRNA levels analysis from saliva samples
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2023to 31 May 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Ultimate Frisbee team athletes of a university
Who may be able to join
- Not suffering from an acute illness
- Not having had an orthopedic injury in the last 12 weeks may prevent them from exercising
- Volunteering to participate in the study
Who cannot join
- Presence of an acute disease
- Having an orthopedic injury that may prevent exercise in the last 12 weeks
- Regular use of medication and/or dietary supplements
- Presence of a chronic \& systemic disease
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University
Istanbul, 34755
Mehmet A Pekdaş, Research Assistant, 02165780000 ext. 3783, alperen.pekdas@yeditepe.edu.tr
Feryal Subaşı, Prof. Dr., 02165780000 ext. 3216, feryal.subasi@yeditepe.edu.tr
About this study
Official title: Investigation of MicroRNA-1 (miRNA-1) and MicroRNA-133a (miRNA-133a) Levels After Acute Neuromuscular Exercise in Ultimate Frisbee Athletes
"The goal of this clinical trial is to investigate the levels of microRNA-1 (miRNA-1) and microRNA-133a (miRNA-133a) after acute neuromuscular exercise (NME) in human saliva.
The main questions it aims to answer are:
- How do miRNA-1 and miRNA-133a levels change in response to acute neuromuscular exercise in human saliva?
- Will the chosen training method have an acute effect in ultimate frisbee athletes?
Participants will:
- Undergo acute neuromuscular exercise (NME).
- Provide saliva samples for miRNA analysis.
Researchers will compare:
MiRNA-1 and miRNA-133a levels before and after acute neuromuscular exercise (NME) to determine if exercise induces any significant changes in these microRNA levels."
Read the detailed description
The genetic material in humans and other living things is DNA, and the information in DNA is transcribed into RNA, and RNA translates this information into protein through translation. More than 98% of RNA cannot be translated into protein this untranslated part is called non-coding RNA. Of the non-coding RNAs, micro-RNAs (miRNAs) are short RNAs of approximately 21-23 nucleotides in length that do not code for proteins and that control gene expression after transcription. miRNAs can partially bind to target messenger RNAs (mRNAs), suppressing protein production or silencing gene expression by splicing target mRNAs. miRNAs enable cell differentiation and development by using the translational repression mechanism. In addition to these roles, miRNAs play a role in many points such as cellular metabolism, repair mechanisms, signaling, cell division, and apoptosis pathways. Studies also identify miRNAs as essential intracellular mediators of processes involved in exercise adaptation, including angiogenesis, inflammation, mitochondrial metabolism, cardiac and skeletal muscle contraction force generation, and tissue hypertrophy. There is evidence that the miRNA may play an important role in regulating the plasticity of the skeletal muscles, such as the hypertrophy of the skeletal muscles, or in regulating the functional properties of the muscle. More than 2000 miRNAs have been identified in humans, and some of them are found and function in the human body in a tissue-specific manner. For example, miRNAs, mostly found in muscle tissue and therefore called myomiRs, are involved in proliferation, muscle cell differentiation, metabolism, and hypertrophy in skeletal and cardiac muscles. The myomiR class includes miR-1, miR-133a, miR-133b, miR-206, miR-208a, miR-208b, miR-486, and miR-499. In the literature, studies examine miRNA levels before and after using various exercise modalities. It has been stated that different miRNAs provide responses such as ventricular compliance, hypertrophy, angiogenesis, and mitochondrial biogenesis after acute or chronic exercise. It has been shown in many studies that these responses, decreased or increased miRNA levels after exercise, are related to the target genes they affect, such as IGF-1, PGC-1α, MAPK, TGF-β, COL1A1, and FOXJ3.
The aim of the study is to investigate the levels of miRNA-1 and miRNA-133a levels after acute neuromuscular exercise (NME) in human saliva.
- Being tested
- miRNA levels analysis from saliva samples
- Keywords
- microRNA, acute exercise, skeletal muscle, exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA levels analysis from saliva samplesOther
Each participant will be given two 50-mL Falcon tubes and will be asked to expectorate a small amount (about 1 mL) of saliva before and immediately after the end of exercise. Part of each saliva sample will be mixed with an equal volume of denaturing solution included in the mirVanaTM PARISTM kit from Ambion, Foster City, CA, in order to inactivate ribonucleases. Serum samples will be separated by centrifugation at 4000 rpm from the saliva samples taken into the biochemistry tubes of the participants and controls and will be raised to -80 centigrade degrees until the study day. Micro RNA will be isolated from serum samples on the working day. Determination of microRNA expression levels (micro RNA-1 and micro RNA-133a) will be determined by reverse transcriptase polymerase chain reaction (RT-PCR) (Applied Biosystems 7500 Fast Real-Time PCR).
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of miRNA-1 and miRNA-133a levels before and after acute neuromuscular exercise
Measured: Approximately 1.5 hours for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start11 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for To Determine the Levels of miRNA1 and miRNA133a Before and After ExerciseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Alperen Pekdaş, Yeditepe University
- Investigators
- Turgay İsbir, Prof. Dr., Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083610
- Sponsor's protocol ID
- 14
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Safdar A, Abadi A, Akhtar M, Hettinga BP, Tarnopolsky MA. miRNA in the regulation of skeletal muscle adaptation to acute endurance exercise in C57Bl/6J male mice. PLoS One. 2009;4(5):e5610. doi: 10.1371/journal.pone.0005610. Epub 2009 May 19.
PubMed 19440340McCarthy JJ, Esser KA. MicroRNA-1 and microRNA-133a expression are decreased during skeletal muscle hypertrophy. J Appl Physiol (1985). 2007 Jan;102(1):306-13. doi: 10.1152/japplphysiol.00932.2006. Epub 2006 Sep 28.
PubMed 17008435Ultimo S, Zauli G, Martelli AM, Vitale M, McCubrey JA, Capitani S, Neri LM. Influence of physical exercise on microRNAs in skeletal muscle regeneration, aging and diseases. Oncotarget. 2018 Mar 30;9(24):17220-17237. doi: 10.18632/oncotarget.24991. eCollection 2018 Mar 30.
PubMed 29682218
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of MicroRNA-1 (miRNA-1) and MicroRNA-133a (miRNA-133a) Levels After Acute Neuromuscular Exercise in Ultimate Frisbee Athletes
- ClinicalTrials.gov ID
- NCT06083610
- Acronym / sponsor ID
- 14
- Keywords
- microRNA, acute exercise, skeletal muscle, exercise training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 16 Oct 2023 (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.
"The goal of this clinical trial is to investigate the levels of microRNA-1 (miRNA-1) and microRNA-133a (miRNA-133a) after acute neuromuscular exercise (NME) in human saliva.
The main questions it aims to answer are:
- How do miRNA-1 and miRNA-133a levels change in response to acute neuromuscular exercise in human saliva?
- Will the chosen training method have an acute effect in ultimate frisbee athletes?
Participants will:
- Undergo acute neuromuscular exercise (NME).
- Provide saliva samples for miRNA analysis.
Researchers will compare:
MiRNA-1 and miRNA-133a levels before and after acute neuromuscular exercise (NME) to determine if exercise induces any significant changes in these microRNA levels."
Detailed description
The genetic material in humans and other living things is DNA, and the information in DNA is transcribed into RNA, and RNA translates this information into protein through translation. More than 98% of RNA cannot be translated into protein this untranslated part is called non-coding RNA. Of the non-coding RNAs, micro-RNAs (miRNAs) are short RNAs of approximately 21-23 nucleotides in length that do not code for proteins and that control gene expression after transcription. miRNAs can partially bind to target messenger RNAs (mRNAs), suppressing protein production or silencing gene expression by splicing target mRNAs. miRNAs enable cell differentiation and development by using the translational repression mechanism. In addition to these roles, miRNAs play a role in many points such as cellular metabolism, repair mechanisms, signaling, cell division, and apoptosis pathways. Studies also identify miRNAs as essential intracellular mediators of processes involved in exercise adaptation, including angiogenesis, inflammation, mitochondrial metabolism, cardiac and skeletal muscle contraction force generation, and tissue hypertrophy. There is evidence that the miRNA may play an important role in regulating the plasticity of the skeletal muscles, such as the hypertrophy of the skeletal muscles, or in regulating the functional properties of the muscle. More than 2000 miRNAs have been identified in humans, and some of them are found and function in the human body in a tissue-specific manner. For example, miRNAs, mostly found in muscle tissue and therefore called myomiRs, are involved in proliferation, muscle cell differentiation, metabolism, and hypertrophy in skeletal and cardiac muscles. The myomiR class includes miR-1, miR-133a, miR-133b, miR-206, miR-208a, miR-208b, miR-486, and miR-499. In the literature, studies examine miRNA levels before and after using various exercise modalities. It has been stated that different miRNAs provide responses such as ventricular compliance, hypertrophy, angiogenesis, and mitochondrial biogenesis after acute or chronic exercise. It has been shown in many studies that these responses, decreased or increased miRNA levels after exercise, are related to the target genes they affect, such as IGF-1, PGC-1α, MAPK, TGF-β, COL1A1, and FOXJ3.
The aim of the study is to investigate the levels of miRNA-1 and miRNA-133a levels after acute neuromuscular exercise (NME) in human saliva.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ultimate Frisbee team athletes of a university
Key inclusion criteria (3 listed)
- Not suffering from an acute illness
- Not having had an orthopedic injury in the last 12 weeks may prevent them from exercising
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Presence of an acute disease
- Having an orthopedic injury that may prevent exercise in the last 12 weeks
- Regular use of medication and/or dietary supplements
- Presence of a chronic \& systemic disease
- Not volunteering to participate in the study
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 |
|---|---|---|
| miRNA levels analysis from saliva samplesEach participant will be given two 50-mL Falcon tubes and will be asked to expectorate a small amount (about 1 mL) of saliva before and immediately after the end of exercise. Part of each saliva sample will be mixed with an equal volume of denaturing solution included in the mirVanaTM PARISTM kit from Ambion, Foster City, CA, in order to inactivate ribonucleases. Serum samples will be separated by centrifugation at 4000 rpm from the saliva samples taken into the biochemistry tubes of the participants and controls and will be raised to -80 centigrade degrees until the study day. Micro RNA will be isolated from serum samples on the working day. Determination of microRNA expression levels (micro RNA-1 and micro RNA-133a) will be determined by reverse transcriptase polymerase chain reaction (RT-PCR) (Applied Biosystems 7500 Fast Real-Time PCR). | Other | – |
Primary outcome
Determination of miRNA-1 and miRNA-133a levels before and after acute neuromuscular exercise
Time frame: Approximately 1.5 hours for each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Results publication: PubMed 19440340Safdar A, Abadi A, Akhtar M, Hettinga BP, Tarnopolsky MA. miRNA in the regulation of skeletal muscle adaptation to acute endurance exercise in C57Bl/6J male mice. PLoS One. 2009;4(5):e5610. doi: 10.1371/journal.pone.0005610. Epub 2009 May 19.
- Results publication: PubMed 17008435McCarthy JJ, Esser KA. MicroRNA-1 and microRNA-133a expression are decreased during skeletal muscle hypertrophy. J Appl Physiol (1985). 2007 Jan;102(1):306-13. doi: 10.1152/japplphysiol.00932.2006. Epub 2006 Sep 28.
- Results publication: PubMed 29682218Ultimo S, Zauli G, Martelli AM, Vitale M, McCubrey JA, Capitani S, Neri LM. Influence of physical exercise on microRNAs in skeletal muscle regeneration, aging and diseases. Oncotarget. 2018 Mar 30;9(24):17220-17237. doi: 10.18632/oncotarget.24991. eCollection 2018 Mar 30.
- Individual participant dataSharing planned: Undecided
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.
Turgay İsbir, Prof. Dr. principal investigator
Yeditepe University
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 To Determine the Levels of miRNA1 and miRNA133a Before and After Exercise, run by Yeditepe 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 3 inclusion and 5 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 16 Oct 2023. 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?
Contact Mehmet A Pekdaş, Research Assistant (02165780000 ext. 3783, alperen.pekdas@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of miRNA-1 and miRNA-133a levels before and after acute neuromuscular exercise (time frame: Approximately 1.5 hours for each participant). 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 NCT06083610, which also lists 3 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 16 Oct 2023.