NCT03279380

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

September 4, 2017

Last Update Submit

September 11, 2017

Conditions

Keywords

genetic polymorphismsport performancemyokines

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks

Secondary Outcomes (1)

  • Concentration of circulating myokines

    12 weeks

Study Arms (3)

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.

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).

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).

Other: Low Intensity Continuous Training

Interventions

SNPOTHER

Screening 150 endurance, 150 power athletes, and 200 healthy control individuals for genetic variant associated to sport performance.

Single-nucleotide polymorphisms (SNPs)

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.

High Intensity Interval Training (HIIT)

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.

Low Intensity Continuous Training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Slovenian residents
  • Healthy individuals
  • endurance athlete (categorization: world, international, national or youth class)
  • power athlete (categorization: world, international, national or youth class)

You may not qualify if:

  • corticosteroids
  • hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty Health Sciences AND Faculty of Mathematics, Natural Sciences and Information Technologies

Koper, 6000, Slovenia

RECRUITING

Related Publications (14)

  • 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.

    PMID: 19653005BACKGROUND
  • Ahmetov 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.

    PMID: 26231489BACKGROUND
  • Booth 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
  • 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.

    PMID: 21183627BACKGROUND
  • Bouchard C. Genomic predictors of trainability. Exp Physiol. 2012 Mar;97(3):347-52. doi: 10.1113/expphysiol.2011.058735. Epub 2011 Oct 3.

    PMID: 21967902BACKGROUND
  • De 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.

    PMID: 18179392BACKGROUND
  • Egan 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.

    PMID: 24069271BACKGROUND
  • Eynon 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.

    PMID: 20647061BACKGROUND
  • Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.

    PMID: 21177953BACKGROUND
  • Pitsiladis 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.

    PMID: 26715623BACKGROUND
  • Rankinen 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.

    PMID: 26824906BACKGROUND
  • Timmons 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.

    PMID: 20133430BACKGROUND
  • Trayhurn 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.

    PMID: 21158485BACKGROUND
  • Yang 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.

    PMID: 15618316BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nejc Sarabon, PhD

    University of Primorska, Faculty of Health Studies, Izola, Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felicita Urzi, MSc

CONTACT

Elena Buzan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr. Sc.

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 12, 2017

Study Start

October 1, 2017

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations