HealthyNCT04985006
Effect of Exercise Intensity on Epigenetic Response in Healthy Young Adult
A study testing running at moderate intensity and running at high intensity in people with Healthy, run by Rahmaningsih Mara Sabirin at 1 site in Indonesia.
Trial summary
Aerobic exercise has been shown to trigger a variety of body responses which then trigger physiological adaptations. One of the physiological adaptations that occur is an increase in mitochondrial biogenesis. Mitochondria are organelles in cells that play a role in providing energy. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- running at moderate intensity and running at high intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2020to 1 Feb 2022
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI <30
- systolic blood pressure <140 mmHg
- diastolic blood pressure <90 mmHg
- have no chronic disease
- have no complaints related to the musculoskeletal, respiratory and cardiovascular systems
- willing to to come to the laboratory
- willing to sign the informed consent form
Who cannot join
- suffer from chronic disease
- have complaints related to the musculoskeletal, respiratory, and cardiovascular systems
- have a history of smoking, both active and passive in the past year
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Physiology. Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada
Sleman, Special Region of Yogyakarta, 55281
About this study
Aerobic exercise has been shown to trigger a variety of body responses which then trigger physiological adaptations. One of the physiological adaptations that occur is an increase in mitochondrial biogenesis. Mitochondria are organelles in cells that play a role in providing energy. An increase in the number of mitochondria will increase the supply of energy for muscle cell contraction, so that muscles do not get tired easily.
Mitochondrial biogenesis is known to be regulated by Peroxisome proliferator-activated receptor gamma co-activator-1 alpha (PGC-1α), by inducing transcription of genes encoded by the nucleus and mitochondria. Peroxisome proliferator-activated receptor gamma co-activator-1 alpha is a protein which encoded by the PPARGC1A gene. PPARGC1A gene expression itself can be influenced by microRNA, a short non-coding RNA that can regulate gene expression by suppressing or degrading the target gene. In vitro studies show that PPARGC1A gene is a direct gene target of microRNA (miR)-23a.
Read more
In human studies, aerobic exercise has been shown to reduce miR-23a levels in human muscles immediately after exercise. Another study found an increase in muscle PGC-1 alpha levels after exercise. In addition to being detectable in muscle, both miR-23a and PGC-1 alpha can be measured in blood plasma. However, whether exercise can reduce miR-23a levels while increasing PGC-1 alpha levels in circulation, still needs further research. Therefore, this study aims to examine whether aerobic exercise will reduce miR-23a levels and PGC-1 alpha levels in plasma. In addition, this study will also compare whether exercise intensity affects the expression of miR-23a and PGC-1 alpha.
In this study, measurements will be made on blood plasma to reduce the level of invasiveness. Subjects will be asked to come to the laboratory three times. The first meeting consisted of an examination, while in the second and third meetings the subjects would be asked to run at a moderate or high intensity. Blood sampling will be done before and after exercise.
Read the detailed description
This study is a randomized cross-over trial with a pre and post intervention measurement. In general, each subject will be asked to run with moderate and vigorous intensity in a random order. Healthy males aged 18-25 were recruited through announcements on social media. Subjects who are willing to join are asked to fill out a form via google forms. Subjects who meet the inclusion and exclusion criteria will be asked to come to the laboratory. At the first meeting, participants will be examined to ensure the subject meets the criteria. The examinations conducted including measurement of body weight, body height, blood pressure, lung function, and electrocardiography. Body weight will be measured using a digital weight scale, while body height will be measured three times using a stadiometer. For measuring the a blood pressure, the subject was asked to lie down for at least 5 minutes. Blood pressure will be measured three times on the right arm using the Omron digital sphygmomanometer. Lung function examination including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and maximal voluntary ventilation (MVV) will be measured using a spirometer. Following the standard procedure from American Thoracic Society/ European Respiratory Society regarding spirometry examination, measurements will be performed in an upright sitting position. Measurement of FVC and FEV1 will be performed at least three times, while MVV will be performed at least twice to obtain reliable and acceptable results. Only healthy subject will be included in the study.
At least 48 hours to 14 days after the first meeting, subjects will be asked to come to the second and third meetings to do moderate or high intensity exercise in randomized order. Before and after exercise, 3 ml of blood will be drawn from the cubital vein and put in an Ethylenediamine tetra acetic acid (EDTA) tube to collect the plasma. The plasma will then be centrifuged to separate the plasma from the blood cells. Plasma is stored in the freezer -80 degrees celsius until it will be used.
The microRNA levels before and after exercise will be measured using real time polymerase chain reaction (qPCR). In general, RNA extraction will be conduct using the plasma extraction kit, following by complement DNA synthesis and qPCR. Normalization will be conduct by adding 3.5 micro liters of cel-miR-39 spike in control to each sample. Quantification of the microRNA level will be expressed as 2-[(CT microRNA)-(CT cel-miR-39)].
Normality test will be performed using Shapiro-Wilk test. If the data is normally distributed, the statistical test of the measurement results before and after exercise at both intensities will be analyzed using independent t-test. Meanwhile, if the data is not normally distributed, statistical analysis will be done using Mann Whitney test.
- Conditions
- Healthy
- Being tested
- running at moderate intensity, running at high intensity
- Keywords
- microRNA, exercise, aerobic exercise, epigenetic, mitochondrial biogenesis
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running at moderate intensityBehavioural
intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 50-59% Heart rate reserve (HRR) for 30 minutes from the time the target intensity is reached.
running at high intensityBehavioural
intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 70-75% HRR for 30 minutes from the time the target intensity is reached.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity aerobic exercise | Experimental | each subject will undergo running in medium intensity. Receives: Behavioral: running at moderate intensity |
| High intensity aerobic exercise | Active comparator | each subject will undergo running in high intensity. Receives: Behavioral: running at high intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-23a level in plasma
microRNA level will be measured using qpCR. Ce-miR-39 spike in control will be added for normalization. Quantification of the microRNA level will be expressed as 2-[(CT microRNA)-(CT cel-miR-39)].
Measured: Before and immediately after exercise
PGC 1 alpha level in plasma
PGC 1 alpha level will be measured using ELISA. The result will be obtained in nanograms.
Measured: Before and immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Oct 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All the participant will be asked to run in moderate and high intensity in random order. The interval between the first exercise and the next is 48 hours to 14 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahmaningsih Mara Sabirin
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia
- Responsible party
- Sponsor-investigator, Rahmaningsih Mara Sabirin, Gadjah Mada University
- Investigators
- Rahmaningsih M Sabirin, MD, M.Sc, Principal investigator, Department of Physiology. Faculty of Medicine, Public Health and Nursing. Universitas Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985006
- Sponsor's protocol ID
- RMS01
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Intensity on Epigenetic Response in Healthy Young Adult
- ClinicalTrials.gov ID
- NCT04985006
- Acronym / sponsor ID
- RMS01
- Conditions
- Healthy
- Keywords
- microRNA, exercise, aerobic exercise, epigenetic, mitochondrial biogenesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rahmaningsih Mara SabirinUniversity, hospital or other
- Collaborators
- Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 2 Aug 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.
Aerobic exercise has been shown to trigger a variety of body responses which then trigger physiological adaptations. One of the physiological adaptations that occur is an increase in mitochondrial biogenesis. Mitochondria are organelles in cells that play a role in providing energy. An increase in the number of mitochondria will increase the supply of energy for muscle cell contraction, so that muscles do not get tired easily.
Mitochondrial biogenesis is known to be regulated by Peroxisome proliferator-activated receptor gamma co-activator-1 alpha (PGC-1α), by inducing transcription of genes encoded by the nucleus and mitochondria. Peroxisome proliferator-activated receptor gamma co-activator-1 alpha is a protein which encoded by the PPARGC1A gene. PPARGC1A gene expression itself can be influenced by microRNA, a short non-coding RNA that can regulate gene expression by suppressing or degrading the target gene. In vitro studies show that PPARGC1A gene is a direct gene target of microRNA (miR)-23a.
In human studies, aerobic exercise has been shown to reduce miR-23a levels in human muscles immediately after exercise. Another study found an increase in muscle PGC-1 alpha levels after exercise. In addition to being detectable in muscle, both miR-23a and PGC-1 alpha can be measured in blood plasma. However, whether exercise can reduce miR-23a levels while increasing PGC-1 alpha levels in circulation, still needs further research. Therefore, this study aims to examine whether aerobic exercise will reduce miR-23a levels and PGC-1 alpha levels in plasma. In addition, this study will also compare whether exercise intensity affects the expression of miR-23a and PGC-1 alpha.
In this study, measurements will be made on blood plasma to reduce the level of invasiveness. Subjects will be asked to come to the laboratory three times. The first meeting consisted of an examination, while in the second and third meetings the subjects would be asked to run at a moderate or high intensity. Blood sampling will be done before and after exercise.
Detailed description
This study is a randomized cross-over trial with a pre and post intervention measurement. In general, each subject will be asked to run with moderate and vigorous intensity in a random order. Healthy males aged 18-25 were recruited through announcements on social media. Subjects who are willing to join are asked to fill out a form via google forms. Subjects who meet the inclusion and exclusion criteria will be asked to come to the laboratory. At the first meeting, participants will be examined to ensure the subject meets the criteria. The examinations conducted including measurement of body weight, body height, blood pressure, lung function, and electrocardiography. Body weight will be measured using a digital weight scale, while body height will be measured three times using a stadiometer. For measuring the a blood pressure, the subject was asked to lie down for at least 5 minutes. Blood pressure will be measured three times on the right arm using the Omron digital sphygmomanometer. Lung function examination including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and maximal voluntary ventilation (MVV) will be measured using a spirometer. Following the standard procedure from American Thoracic Society/ European Respiratory Society regarding spirometry examination, measurements will be performed in an upright sitting position. Measurement of FVC and FEV1 will be performed at least three times, while MVV will be performed at least twice to obtain reliable and acceptable results. Only healthy subject will be included in the study.
At least 48 hours to 14 days after the first meeting, subjects will be asked to come to the second and third meetings to do moderate or high intensity exercise in randomized order. Before and after exercise, 3 ml of blood will be drawn from the cubital vein and put in an Ethylenediamine tetra acetic acid (EDTA) tube to collect the plasma. The plasma will then be centrifuged to separate the plasma from the blood cells. Plasma is stored in the freezer -80 degrees celsius until it will be used.
The microRNA levels before and after exercise will be measured using real time polymerase chain reaction (qPCR). In general, RNA extraction will be conduct using the plasma extraction kit, following by complement DNA synthesis and qPCR. Normalization will be conduct by adding 3.5 micro liters of cel-miR-39 spike in control to each sample. Quantification of the microRNA level will be expressed as 2-[(CT microRNA)-(CT cel-miR-39)].
Normality test will be performed using Shapiro-Wilk test. If the data is normally distributed, the statistical test of the measurement results before and after exercise at both intensities will be analyzed using independent t-test. Meanwhile, if the data is not normally distributed, statistical analysis will be done using Mann Whitney test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All the participant will be asked to run in moderate and high intensity in random order. The interval between the first exercise and the next is 48 hours to 14 days.
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity aerobic exercise | Experimental | Behavioral: running at moderate intensityeach subject will undergo running in medium intensity. |
| High intensity aerobic exercise | Active comparator | Behavioral: running at high intensityeach subject will undergo running in high intensity. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy
- BMI <30
- systolic blood pressure <140 mmHg
- diastolic blood pressure <90 mmHg
- have no chronic disease
Key exclusion criteria (3 listed)
- suffer from chronic disease
- have complaints related to the musculoskeletal, respiratory, and cardiovascular systems
- have a history of smoking, both active and passive in the past year
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 |
|---|---|---|
| running at moderate intensityintensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 50-59% Heart rate reserve (HRR) for 30 minutes from the time the target intensity is reached. | Behavioural | Moderate intensity aerobic exercise |
| running at high intensityintensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 70-75% HRR for 30 minutes from the time the target intensity is reached. | Behavioural | High intensity aerobic exercise |
Primary outcome
miR-23a level in plasma
Time frame: Before and immediately after exercise
microRNA level will be measured using qpCR. Ce-miR-39 spike in control will be added for normalization. Quantification of the microRNA level will be expressed as 2-[(CT microRNA)-(CT cel-miR-39)].
PGC 1 alpha level in plasma
Time frame: Before and immediately after exercise
PGC 1 alpha level will be measured using ELISA. The result will be obtained in nanograms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- 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.
Rahmaningsih M Sabirin, MD, M.Sc principal investigator
Department of Physiology. Faculty of Medicine, Public Health and Nursing. Universitas Gadjah Mada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running at moderate intensity and running at high intensity in people with Healthy, run by Rahmaningsih Mara Sabirin at 1 site in Indonesia.
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 8 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 22 Sep 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 Indonesia. 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?
miR-23a level in plasma (time frame: Before and immediately after exercise). The study lists 2 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 22 Sep 2021.