Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04985006 |
| Other study ID # |
RMS01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
September 2021 |
| Source |
Gadjah Mada University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
