NCT03990259

Brief Summary

This study has as main objective to asses different genetic, biochemical and physiological biomarkers affecting performance and health status in ultraendurance runners according to individual's sex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

May 20, 2019

Last Update Submit

June 17, 2019

Conditions

Keywords

UltraenduranceSex differencesPerformanceGeneticsPhysiological damage

Outcome Measures

Primary Outcomes (12)

  • Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage

    Blood concentration of estradiol, testosterone, progesterone, creatinine, troponin, C-reactive protein, hemoglobin, sodium, potassium, chlorine, iron, and ferritin. Concentration of all these parameters is expressed in mass per volume (i.e. nanograms per milliliter)

    12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race

  • Change in the biochemical parameters related to muscle damage

    Blood concentration of lactate dehydrogenase and creatine kinase. The enzyme concentration is expressed in units per volume (enzyme units per milliliter)

    12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race

  • Change in the biochemical parameters related to immunological response

    Blood concentration of erythrocytes, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet volume. The concentration of each cell type is expressed in number of cells per volume (cells per liter)

    12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race

  • Change in the power level

    Squat Jump (high of the jump measured in centimeters)

    12 hours before the race, 15 minutes after the race

  • Change in the lung function

    Pulmonary function test by spirometry. The parameters measured are vital capacity (VC), forced vital capacity (FVC), maximal mid-expiratory flow (MEF) and total lung capacity. Outcome data of all these parameters are expressed in liters.

    12 hours before the race, and 15 minutes after the race

  • Change in the lung function related to time

    Pulmonary function test by spirometry. The parameters measured are forced expiratory volume in 1 second (FEV1) and in 6 seconds (FEV6) and peak expiratory flow (PEF). Outcome data of all these parameters are expressed in liters per second.

    12 hours before the race, and 15 minutes after the race

  • Change in the Strength level

    Hand grip (pressure in kilograms)

    12 hours before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race

  • Change in the Ventilatory Flow

    Ventilatory Flow measurement (liters per minute)

    60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race

  • Change in the biochemical parameters related to dehydration and kidney injury

    Urine test to measure the concentration of sodium and creatinine, as well as urine density

    60 minutes before the race and 15 minutes after the race

  • Analysis of tne changes in the Physical activity data

    Physical activity measured by wearing accelerometer devices. Physical activity defined as sedentary, light, moderate, vigorous, very vigorous and extremely vigorous. The aim to wear accelerometers devices is to monitor individuals.

    From 9 hours before starting the race to 48 hours after crossing the finish line.

  • Analysis of the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery

    Analysis of different polymorphisms in genomic DNA samples, which were isolated from the saliva sample of each participant.

    12 hours before the race

  • Telomere length, genetic marker related to biological aging

    Analysis of the telomere length in genomic DNA samples, which were isolated from saliva samples of each participant

    12 hours before the race

Secondary Outcomes (9)

  • Self-reported questionnaire about social and health status

    One month before the race day

  • Self-reported questionnaire about training habits

    One month before the race day

  • Self-reported questionnaire about menstrual cycle (only for females)

    One month before the race day

  • Assesment of physical condition by cardiopulmonary test

    One month before the race day

  • Analysis of body composition (proportion of body fat, fat-free mass and water) per body areas (trunk, arms and legs)

    12 hours before the race, and 15 minutes after the race,

  • +4 more secondary outcomes

Study Arms (2)

Male

The male individuals of the study population

Other: Running the CSP Mountain Race

Female

The female individuals of the study population

Other: Running the CSP Mountain Race

Interventions

The runners completed a 107,6 km mountain race

FemaleMale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 ultraendurance amateur runners, 19 females and 31 males.

You may qualify if:

  • Healthy adults (\>18 years old)
  • Volunteers should be finish at least one ultraendurance mountain race (\>60km).

You may not qualify if:

  • Having heart disease
  • Having kidney disease
  • Taking a medication on an ongoing basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Jaume I

Castellon, 12071, Spain

Location

Related Publications (10)

  • Cheuvront SN, Carter R, Deruisseau KC, Moffatt RJ. Running performance differences between men and women:an update. Sports Med. 2005;35(12):1017-24. doi: 10.2165/00007256-200535120-00002.

    PMID: 16336006BACKGROUND
  • Eichenberger E, Knechtle B, Rust CA, Rosemann T, Lepers R. Age and sex interactions in mountain ultramarathon running - the Swiss Alpine Marathon. Open Access J Sports Med. 2012 Jul 31;3:73-80. doi: 10.2147/OAJSM.S33836. eCollection 2012.

    PMID: 24198590BACKGROUND
  • Gimenez P, Kerherve H, Messonnier LA, Feasson L, Millet GY. Changes in the energy cost of running during a 24-h treadmill exercise. Med Sci Sports Exerc. 2013 Sep;45(9):1807-13. doi: 10.1249/MSS.0b013e318292c0ec.

    PMID: 23524515BACKGROUND
  • Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.

    PMID: 30157271BACKGROUND
  • Joyner MJ. Physiological limits to endurance exercise performance: influence of sex. J Physiol. 2017 May 1;595(9):2949-2954. doi: 10.1113/JP272268. Epub 2017 Feb 9.

    PMID: 28028816BACKGROUND
  • Knechtle B, Knechtle P, Rosemann T, Lepers R. Personal best marathon time and longest training run, not anthropometry, predict performance in recreational 24-hour ultrarunners. J Strength Cond Res. 2011 Aug;25(8):2212-8. doi: 10.1519/JSC.0b013e3181f6b0c7.

    PMID: 21642857BACKGROUND
  • Knechtle B, Knechtle P, Wirth A, Alexander Rust C, Rosemann T. A faster running speed is associated with a greater body weight loss in 100-km ultra-marathoners. J Sports Sci. 2012;30(11):1131-40. doi: 10.1080/02640414.2012.692479. Epub 2012 Jun 6.

    PMID: 22668199BACKGROUND
  • Ahmetov I, Kulemin N, Popov D, Naumov V, Akimov E, Bravy Y, Egorova E, Galeeva A, Generozov E, Kostryukova E, Larin A, Mustafina Lj, Ospanova E, Pavlenko A, Starnes L, Zmijewski P, Alexeev D, Vinogradova O, Govorun V. Genome-wide association study identifies three novel genetic markers associated with elite endurance performance. Biol Sport. 2015 Mar;32(1):3-9. doi: 10.5604/20831862.1124568. Epub 2014 Oct 21.

    PMID: 25729143BACKGROUND
  • Borghini A, Giardini G, Tonacci A, Mastorci F, Mercuri A, Mrakic-Sposta S, Moretti S, Andreassi MG, Pratali L. Chronic and acute effects of endurance training on telomere length. Mutagenesis. 2015 Sep;30(5):711-6. doi: 10.1093/mutage/gev038. Epub 2015 May 22.

    PMID: 26001753BACKGROUND
  • Martinez-Navarro I, Aparicio I, Priego-Quesada JI, Perez-Soriano P, Collado E, Hernando B, Hernando C. Effects of wearing a full body compression garment during recovery from an ultra-trail race. Eur J Sport Sci. 2021 Jun;21(6):811-818. doi: 10.1080/17461391.2020.1783369. Epub 2020 Jun 30.

Biospecimen

Retention: SAMPLES WITH DNA

The genomic DNA was isolated from a saliva sample

Study Officials

  • Carlos Hernando, PhD

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 18, 2019

Study Start

February 25, 2019

Primary Completion

April 4, 2019

Study Completion

April 16, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

It is not planned to share participant's data

Locations