ExerciseGE-EXNCT03279380
Gene-Exercise Interactions in Athletes
A study testing SNP, High Intensity Interval Training (HIIT) and Low Intensity Continuous Training in people with Exercise, run by University of Primorska at 1 site in Slovenia.
Trial summary
Athlete status is a heritable trait that could be explained with a number of potentially important DNA polymorphisms contributing to predisposition to success in certain types of sport. The first aim of the study is to determine the genetic profile of Slovenian athletes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- SNP, High Intensity Interval Training (HIIT) and Low Intensity Continuous Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2017to 30 Jun 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Slovenian residents
- Healthy individuals
- endurance athlete (categorization: world, international, national or youth class)
- power athlete (categorization: world, international, national or youth class)
Who cannot join
- corticosteroids
- hormone therapy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University of Primorska, Faculty Health Sciences AND Faculty of Mathematics, Natural Sciences and Information Technologies
Koper, 6000
Felicita Urzi, MSc, 0038631801692, felicita.urzi@upr.si
Elena Buzan, PhD, 0038641350957, elena.buzan@upr.si
About this study
Official title: Acute Physiological Response to Exercise in Athletes Selected According to Candidate Gene Polymorphisms Associated With Endurance Phenotype
Athlete status is a heritable trait that could be explained with a number of potentially important DNA polymorphisms contributing to predisposition to success in certain types of sport.
The first aim of the study is to determine the genetic profile of Slovenian athletes. The associations of 30 common gene polymorphisms with aerobic and anaerobic athlete status will be investigated as a single and polygenic profile.
The second aim is to investigate the impact of the genetic variants contributing to different acute response to low vs. high intensity exercise. Physiological and biochemical measurements will be carried out. Variability in physiological adaptation in response to exercise will provides an opportunity to study the relationship between the molecular response to exercise and the extent of physiological changes in athletes. Currently, it is not yet clear whether different genetic variant associated with exercise responses remains uniform, with different exercise intensities, structure and duration of exercise.
Read the detailed description
Slovenian athletes (n = 300; 18-40 years) of regional or national competitive standard will be recruited from the endurance oriented and power oriented sports disciplines. Healthy unrelated individuals without any competitive sport experience will serve as controls (n= 200; 18-40 years). After completing the questionnaire (for athletes: covering demographics, geographic ancestry, sports classification, discipline, and history, as well as frequency and volume of training; for control group: demographics, geographic ancestry habits of daily living), genotyping analyses will be performed. The athletes and controls will be genotyped for 30 candidate gene polymorphisms considered likely to influence endurance performance. Molecular genetic analysis will be performed with DNA samples obtained from the capillary whole blood. Genotyping for 30 gene polymorphisms will be performed by Real-Time PCR on LightCycler® 96 Instrument (Roche) and KASP (Kompetitive Allele Specific PCR) genotyping technology.
In addition, 40 athletes with endurance genetic variant will be selected to participate in the acute exercise study. In order to investigate the acute effects of low and high intensity exercise the concentration of circulating myokines will be measured.
Three distinct experimental sessions scheduled 96 h apart, at the same time of the day and in random order will be applied to this sub-group of athletes.
In the first session, aerobic power will be determined using an incremental test to exhaustion on a cycling ergometer (Velodyn, Racermate ™, USA). Oxygen consumption (VO2) will be determined breath by breath using a Quark gas analysis system (Quark, Cosmed, Rim, Italy). The interventions during the other two experimental session will consist of cycling exercise with continuous 60 min cycling at 50% PPO (low intensity), and 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W) exercise (high intensity).
The participants will be asked to follow the prescribed diet regime, to avoid the intake of alcohol and to not perform any physical activity in the 24 hours prior to the experimental sessions. The experimental sessions will be performed from 8 to 11 am, in random order and scheduled 96 h apart.
Before each intervention, the individuals will remain seated in the laboratory for a period of 20 minutes with a room temperature between 22-24ºC. During this period, resting blood samples will be collected. Two more samples of blood will be collected, immediately post-exercise intervention and 2h post-exercise. Venous blood will be collected into EDTA tubes, centrifuge at 2500-3000g for 20 minutes, and a separate plasma will be stored at -80 ° C for the further analysis.
The quantification of biomarkers will be done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore). For the myokine analysis a commercial kit HMYOMAG-56K will be used.
Genotype distribution and allele frequencies between each of the two groups of athletes (endurance and power) and controls will be compared using χ2 tests. Endurance genotype score (EGS) will be construct. First, each genotype will be scored within each polymorphism. Thus, a genotype score (GS) of 2, 1 and 0 to each individual genotype theoretically associated to highest, medium or lowest potential of endurance phenotypes will be assigned. Second, the GS of each single genotype will be summed ∑(i=1)^nSNPi. Third, the EGS will be transformed to a 0-100 scale for easier interpretation, as follows: EGS=(100/2n)∑_(i=1)^nSNPi. An EGS of 100 represents an 'optimal' polygenic profile for endurance athlete-that is, that all GS are 2. In contrast, an EGS of 0 represents the 'worst' possible profile for endurance athlete, that is, all GS are 0. The mean the EGS obtained in the three study groups will be calculated. The EGS of endurance, power athletes and non-athletes (controls) will be compared with one-way analysis of variance (ANOVA), and Tukey post hoc test will be used for between-group comparisons. We will also performed ANOVA to compare the EGS between elite- and national-level athletes within each group of endurance and power athletes. Data normality was verified through an exploratory analysis using the Shapiro-Wilk test. Two-way mixed ANOVA will be applied to check the main interaction effects of time by exercise session (time*session) and of time (time) on myokine plasma concentration. For statistically significant effects, a post-hoc Tukey test will be adopted for multiple comparisons. All values will be expressed as mean and standard deviation (SD). P values of <0.05 will be considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).
- Conditions
- Exercise
- Being tested
- SNP, High Intensity Interval Training (HIIT), Low Intensity Continuous Training
- Keywords
- genetic polymorphism, sport performance, myokines
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNPOther
Screening 150 endurance, 150 power athletes, and 200 healthy control individuals for genetic variant associated to sport performance.
High Intensity Interval Training (HIIT)Other
The subgroup (n = 40) of the athletes will participate in the acute exercises (HIIT Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory at least three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
Low Intensity Continuous TrainingOther
The subgroup (n = 40) of the athletes will participate in the acute exercises (LIT Continuous Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
| Study group | Role | What they receive |
|---|---|---|
| Single-nucleotide polymorphisms (SNPs) | Experimental | In the first part the Case-control study design will be used to estimate the association between multiple single-nucleotide polymorphisms (SNPs) and the endurance/power athlete status. Receives: Other: SNP |
| High Intensity Interval Training (HIIT) | Active comparator | High intensity interval exercise on the cycling ergometer (Velodyn, Racermate ™, USA).
Protocol: 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W). Baseline measurements will include the V̇O2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy). Receives: Other: High Intensity Interval Training (HIIT) |
| Low Intensity Continuous Training | Active comparator | Low intensity continuous exercise on the cycling ergometer (Velodyn, Racermate ™, USA).
Protocol: continuous 60 min cycling at 50% PPO. Baseline measurements will include the V̇o2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy). Receives: Other: Low Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic markers associated with endurance performance
Comparing the frequencies of the alleles of the candidate genes between endurance athletes and opposite cohorts (controls, power athletes).
Measured: 12 weeks
Secondary outcomes (1)
Concentration of circulating myokines
The effect of exercise on expression of myokine between different exercise (high and low intensity exercise).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- S2P, Science to Practice, Ltd.
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Sarabon, PhD, Principal investigator, University of Primorska, Faculty of Health Studies, Izola, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279380
- Sponsor's protocol ID
- UP-FVZ-GeneExerciseInteraction
- Acronym
- GE-EX
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmetov II, Williams AG, Popov DV, Lyubaeva EV, Hakimullina AM, Fedotovskaya ON, Mozhayskaya IA, Vinogradova OL, Astratenkova IV, Montgomery HE, Rogozkin VA. The combined impact of metabolic gene polymorphisms on elite endurance athlete status and related phenotypes. Hum Genet. 2009 Dec;126(6):751-61. doi: 10.1007/s00439-009-0728-4.
PubMed 19653005Ahmetov II, Fedotovskaya ON. Current Progress in Sports Genomics. Adv Clin Chem. 2015;70:247-314. doi: 10.1016/bs.acc.2015.03.003. Epub 2015 Apr 11.
PubMed 26231489Booth FW, Neufer PD (2012) Exercise genomics and proteomics. In: Farrrell PA, Joyner MJ, Caiozzo VJ, editors. ACSM's Advanced Exercise Physiology. Baltimore, MD: Lippincott Williams & Wilkins. pp. 669-698
Bouchard C, Sarzynski MA, Rice TK, Kraus WE, Church TS, Sung YJ, Rao DC, Rankinen T. Genomic predictors of the maximal O(2) uptake response to standardized exercise training programs. J Appl Physiol (1985). 2011 May;110(5):1160-70. doi: 10.1152/japplphysiol.00973.2010. Epub 2010 Dec 23.
PubMed 21183627Bouchard C. Genomic predictors of trainability. Exp Physiol. 2012 Mar;97(3):347-52. doi: 10.1113/expphysiol.2011.058735. Epub 2011 Oct 3.
PubMed 21967902De Moor MH, Spector TD, Cherkas LF, Falchi M, Hottenga JJ, Boomsma DI, De Geus EJ. Genome-wide linkage scan for athlete status in 700 British female DZ twin pairs. Twin Res Hum Genet. 2007 Dec;10(6):812-20. doi: 10.1375/twin.10.6.812.
PubMed 18179392Egan B, O'Connor PL, Zierath JR, O'Gorman DJ. Time course analysis reveals gene-specific transcript and protein kinetics of adaptation to short-term aerobic exercise training in human skeletal muscle. PLoS One. 2013 Sep 12;8(9):e74098. doi: 10.1371/journal.pone.0074098. eCollection 2013.
PubMed 24069271Eynon N, Ruiz JR, Meckel Y, Moran M, Lucia A. Mitochondrial biogenesis related endurance genotype score and sports performance in athletes. Mitochondrion. 2011 Jan;11(1):64-9. doi: 10.1016/j.mito.2010.07.004. Epub 2010 Jul 18.
PubMed 20647061Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
PubMed 21177953Pitsiladis YP, Tanaka M, Eynon N, Bouchard C, North KN, Williams AG, Collins M, Moran CN, Britton SL, Fuku N, Ashley EA, Klissouras V, Lucia A, Ahmetov II, de Geus E, Alsayrafi M; Athlome Project Consortium. Athlome Project Consortium: a concerted effort to discover genomic and other "omic" markers of athletic performance. Physiol Genomics. 2016 Mar;48(3):183-90. doi: 10.1152/physiolgenomics.00105.2015. Epub 2015 Dec 29.
PubMed 26715623Rankinen T, Fuku N, Wolfarth B, Wang G, Sarzynski MA, Alexeev DG, Ahmetov II, Boulay MR, Cieszczyk P, Eynon N, Filipenko ML, Garton FC, Generozov EV, Govorun VM, Houweling PJ, Kawahara T, Kostryukova ES, Kulemin NA, Larin AK, Maciejewska-Karlowska A, Miyachi M, Muniesa CA, Murakami H, Ospanova EA, Padmanabhan S, Pavlenko AV, Pyankova ON, Santiago C, Sawczuk M, Scott RA, Uyba VV, Yvert T, Perusse L, Ghosh S, Rauramaa R, North KN, Lucia A, Pitsiladis Y, Bouchard C. No Evidence of a Common DNA Variant Profile Specific to World Class Endurance Athletes. PLoS One. 2016 Jan 29;11(1):e0147330. doi: 10.1371/journal.pone.0147330. eCollection 2016.
PubMed 26824906Timmons JA, Knudsen S, Rankinen T, Koch LG, Sarzynski M, Jensen T, Keller P, Scheele C, Vollaard NB, Nielsen S, Akerstrom T, MacDougald OA, Jansson E, Greenhaff PL, Tarnopolsky MA, van Loon LJ, Pedersen BK, Sundberg CJ, Wahlestedt C, Britton SL, Bouchard C. Using molecular classification to predict gains in maximal aerobic capacity following endurance exercise training in humans. J Appl Physiol (1985). 2010 Jun;108(6):1487-96. doi: 10.1152/japplphysiol.01295.2009. Epub 2010 Feb 4.
PubMed 20133430Trayhurn P, Drevon CA, Eckel J. Secreted proteins from adipose tissue and skeletal muscle - adipokines, myokines and adipose/muscle cross-talk. Arch Physiol Biochem. 2011 May;117(2):47-56. doi: 10.3109/13813455.2010.535835. Epub 2010 Dec 15.
PubMed 21158485Yang Y, Creer A, Jemiolo B, Trappe S. Time course of myogenic and metabolic gene expression in response to acute exercise in human skeletal muscle. J Appl Physiol (1985). 2005 May;98(5):1745-52. doi: 10.1152/japplphysiol.01185.2004. Epub 2004 Dec 23.
PubMed 15618316
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Physiological Response to Exercise in Athletes Selected According to Candidate Gene Polymorphisms Associated With Endurance Phenotype
- ClinicalTrials.gov ID
- NCT03279380
- Acronym / sponsor ID
- GE-EX / UP-FVZ-GeneExerciseInteraction
- Conditions
- Exercise
- Keywords
- genetic polymorphism, sport performance, myokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- S2P, Science to Practice, Ltd.
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 Sep 2017 (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.
Athlete status is a heritable trait that could be explained with a number of potentially important DNA polymorphisms contributing to predisposition to success in certain types of sport.
The first aim of the study is to determine the genetic profile of Slovenian athletes. The associations of 30 common gene polymorphisms with aerobic and anaerobic athlete status will be investigated as a single and polygenic profile.
The second aim is to investigate the impact of the genetic variants contributing to different acute response to low vs. high intensity exercise. Physiological and biochemical measurements will be carried out. Variability in physiological adaptation in response to exercise will provides an opportunity to study the relationship between the molecular response to exercise and the extent of physiological changes in athletes. Currently, it is not yet clear whether different genetic variant associated with exercise responses remains uniform, with different exercise intensities, structure and duration of exercise.
Detailed description
Slovenian athletes (n = 300; 18-40 years) of regional or national competitive standard will be recruited from the endurance oriented and power oriented sports disciplines. Healthy unrelated individuals without any competitive sport experience will serve as controls (n= 200; 18-40 years). After completing the questionnaire (for athletes: covering demographics, geographic ancestry, sports classification, discipline, and history, as well as frequency and volume of training; for control group: demographics, geographic ancestry habits of daily living), genotyping analyses will be performed. The athletes and controls will be genotyped for 30 candidate gene polymorphisms considered likely to influence endurance performance. Molecular genetic analysis will be performed with DNA samples obtained from the capillary whole blood. Genotyping for 30 gene polymorphisms will be performed by Real-Time PCR on LightCycler® 96 Instrument (Roche) and KASP (Kompetitive Allele Specific PCR) genotyping technology.
In addition, 40 athletes with endurance genetic variant will be selected to participate in the acute exercise study. In order to investigate the acute effects of low and high intensity exercise the concentration of circulating myokines will be measured.
Three distinct experimental sessions scheduled 96 h apart, at the same time of the day and in random order will be applied to this sub-group of athletes.
In the first session, aerobic power will be determined using an incremental test to exhaustion on a cycling ergometer (Velodyn, Racermate ™, USA). Oxygen consumption (VO2) will be determined breath by breath using a Quark gas analysis system (Quark, Cosmed, Rim, Italy). The interventions during the other two experimental session will consist of cycling exercise with continuous 60 min cycling at 50% PPO (low intensity), and 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W) exercise (high intensity).
The participants will be asked to follow the prescribed diet regime, to avoid the intake of alcohol and to not perform any physical activity in the 24 hours prior to the experimental sessions. The experimental sessions will be performed from 8 to 11 am, in random order and scheduled 96 h apart.
Before each intervention, the individuals will remain seated in the laboratory for a period of 20 minutes with a room temperature between 22-24ºC. During this period, resting blood samples will be collected. Two more samples of blood will be collected, immediately post-exercise intervention and 2h post-exercise. Venous blood will be collected into EDTA tubes, centrifuge at 2500-3000g for 20 minutes, and a separate plasma will be stored at -80 ° C for the further analysis.
The quantification of biomarkers will be done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore). For the myokine analysis a commercial kit HMYOMAG-56K will be used.
Genotype distribution and allele frequencies between each of the two groups of athletes (endurance and power) and controls will be compared using χ2 tests. Endurance genotype score (EGS) will be construct. First, each genotype will be scored within each polymorphism. Thus, a genotype score (GS) of 2, 1 and 0 to each individual genotype theoretically associated to highest, medium or lowest potential of endurance phenotypes will be assigned. Second, the GS of each single genotype will be summed ∑(i=1)^nSNPi. Third, the EGS will be transformed to a 0-100 scale for easier interpretation, as follows: EGS=(100/2n)∑_(i=1)^nSNPi. An EGS of 100 represents an 'optimal' polygenic profile for endurance athlete-that is, that all GS are 2. In contrast, an EGS of 0 represents the 'worst' possible profile for endurance athlete, that is, all GS are 0. The mean the EGS obtained in the three study groups will be calculated. The EGS of endurance, power athletes and non-athletes (controls) will be compared with one-way analysis of variance (ANOVA), and Tukey post hoc test will be used for between-group comparisons. We will also performed ANOVA to compare the EGS between elite- and national-level athletes within each group of endurance and power athletes. Data normality was verified through an exploratory analysis using the Shapiro-Wilk test. Two-way mixed ANOVA will be applied to check the main interaction effects of time by exercise session (time*session) and of time (time) on myokine plasma concentration. For statistically significant effects, a post-hoc Tukey test will be adopted for multiple comparisons. All values will be expressed as mean and standard deviation (SD). P values of <0.05 will be considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-nucleotide polymorphisms (SNPs) | Experimental | Other: SNPIn the first part the Case-control study design will be used to estimate the association between multiple single-nucleotide polymorphisms (SNPs) and the endurance/power athlete status. |
| High Intensity Interval Training (HIIT) | Active comparator | Other: High Intensity Interval Training (HIIT)High intensity interval exercise on the cycling ergometer (Velodyn, Racermate ™, USA). Protocol: 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W). Baseline measurements will include the V̇O2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy). |
| Low Intensity Continuous Training | Active comparator | Other: Low Intensity Continuous TrainingLow intensity continuous exercise on the cycling ergometer (Velodyn, Racermate ™, USA). Protocol: continuous 60 min cycling at 50% PPO. Baseline measurements will include the V̇o2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Slovenian residents
- Healthy individuals
- endurance athlete (categorization: world, international, national or youth class)
- power athlete (categorization: world, international, national or youth class)
Key exclusion criteria (2 listed)
- corticosteroids
- hormone therapy
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 |
|---|---|---|
| SNPScreening 150 endurance, 150 power athletes, and 200 healthy control individuals for genetic variant associated to sport performance. | Other | Single-nucleotide polymorphisms (SNPs) |
| High Intensity Interval Training (HIIT)The subgroup (n = 40) of the athletes will participate in the acute exercises (HIIT Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory at least three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits. | Other | High Intensity Interval Training (HIIT) |
| Low Intensity Continuous TrainingThe subgroup (n = 40) of the athletes will participate in the acute exercises (LIT Continuous Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits. | Other | Low Intensity Continuous Training |
Primary outcome
Genetic markers associated with endurance performance
Time frame: 12 weeks
Comparing the frequencies of the alleles of the candidate genes between endurance athletes and opposite cohorts (controls, power athletes).
1 secondary outcome
Concentration of circulating myokines
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 19653005Ahmetov II, Williams AG, Popov DV, Lyubaeva EV, Hakimullina AM, Fedotovskaya ON, Mozhayskaya IA, Vinogradova OL, Astratenkova IV, Montgomery HE, Rogozkin VA. The combined impact of metabolic gene polymorphisms on elite endurance athlete status and related phenotypes. Hum Genet. 2009 Dec;126(6):751-61. doi: 10.1007/s00439-009-0728-4.
- Background: PubMed 26231489Ahmetov II, Fedotovskaya ON. Current Progress in Sports Genomics. Adv Clin Chem. 2015;70:247-314. doi: 10.1016/bs.acc.2015.03.003. Epub 2015 Apr 11.
- BackgroundBooth FW, Neufer PD (2012) Exercise genomics and proteomics. In: Farrrell PA, Joyner MJ, Caiozzo VJ, editors. ACSM's Advanced Exercise Physiology. Baltimore, MD: Lippincott Williams & Wilkins. pp. 669-698
- Background: PubMed 21183627Bouchard C, Sarzynski MA, Rice TK, Kraus WE, Church TS, Sung YJ, Rao DC, Rankinen T. Genomic predictors of the maximal O(2) uptake response to standardized exercise training programs. J Appl Physiol (1985). 2011 May;110(5):1160-70. doi: 10.1152/japplphysiol.00973.2010. Epub 2010 Dec 23.
- Background: PubMed 21967902Bouchard C. Genomic predictors of trainability. Exp Physiol. 2012 Mar;97(3):347-52. doi: 10.1113/expphysiol.2011.058735. Epub 2011 Oct 3.
- Background: PubMed 18179392De Moor MH, Spector TD, Cherkas LF, Falchi M, Hottenga JJ, Boomsma DI, De Geus EJ. Genome-wide linkage scan for athlete status in 700 British female DZ twin pairs. Twin Res Hum Genet. 2007 Dec;10(6):812-20. doi: 10.1375/twin.10.6.812.
- Background: PubMed 24069271Egan B, O'Connor PL, Zierath JR, O'Gorman DJ. Time course analysis reveals gene-specific transcript and protein kinetics of adaptation to short-term aerobic exercise training in human skeletal muscle. PLoS One. 2013 Sep 12;8(9):e74098. doi: 10.1371/journal.pone.0074098. eCollection 2013.
- Background: PubMed 20647061Eynon N, Ruiz JR, Meckel Y, Moran M, Lucia A. Mitochondrial biogenesis related endurance genotype score and sports performance in athletes. Mitochondrion. 2011 Jan;11(1):64-9. doi: 10.1016/j.mito.2010.07.004. Epub 2010 Jul 18.
- Background: PubMed 21177953Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
- Background: PubMed 26715623Pitsiladis YP, Tanaka M, Eynon N, Bouchard C, North KN, Williams AG, Collins M, Moran CN, Britton SL, Fuku N, Ashley EA, Klissouras V, Lucia A, Ahmetov II, de Geus E, Alsayrafi M; Athlome Project Consortium. Athlome Project Consortium: a concerted effort to discover genomic and other "omic" markers of athletic performance. Physiol Genomics. 2016 Mar;48(3):183-90. doi: 10.1152/physiolgenomics.00105.2015. Epub 2015 Dec 29.
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- 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.
Nejc Sarabon, PhD principal investigator
University of Primorska, Faculty of Health Studies, Izola, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNP, High Intensity Interval Training (HIIT) and Low Intensity Continuous Training in people with Exercise, run by University of Primorska at 1 site in Slovenia.
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 4 inclusion and 2 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 12 Sep 2017. 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 Slovenia. 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 Felicita Urzi, MSc (0038631801692, felicita.urzi@upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic markers associated with endurance performance (time frame: 12 weeks). 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 NCT03279380, which also lists 14 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 12 Sep 2017.