NCT05718752

Brief Summary

Among the various trace elements playing a key role in physical performance, iron is probably one of the most studied in the last 30 years. Iron is an essential component of both hemoglobin and myoglobin allowing an optimal oxygen delivery to organs, especially to skeletal muscle. Iron also plays a major role in the mitochondrial respiratory chain, as well as in the activity of numerous enzymes. Recent studies support the existence of a strong interaction between the iron metabolism and the other non-ferrous trace elements including among others zinc, copper or cobalt. The latter, but also other trace element metals could thus play an important role in physical performance. The finality of this project is thus 1) to determine the variations of plasma iron and non-ferrous metals in response to an acute exercise, 2) better understand the interactions between all these metals, 3) to determine if such responses to exercise are different or not depending on sex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

January 30, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

January 30, 2023

Last Update Submit

June 27, 2024

Conditions

Keywords

Maximal oxygen consumptionPhysical performanceMetallomic profileIron metabolism

Outcome Measures

Primary Outcomes (1)

  • Plasma iron availability

    Serum iron levels and transferrin saturation will be determined before, just after the 30-min continuous ergocycle test and after 3 hours of recovery

    Week 3

Secondary Outcomes (4)

  • Plasma non-ferrous metals levels

    Week 3

  • Plasma metallome fingerprint

    Week 3

  • Erythrocyte non-ferrous metals levels

    Week 3

  • Erythrocyte metallome fingerprint

    Week 3

Study Arms (2)

Healthy men

no intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: 30-min submaximal exercise test

Healthy women

no intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: 30-min submaximal exercise test

Interventions

Gas exchange are measured during all the test on ergocycle until oxygen consumption reach its maximum value

Healthy menHealthy women

A 30-min submaximal test on ergocycle. Gas exchange are measured during all the test. Blood samples are collected before, at the end of exercise and after 3 hours of recovery

Healthy menHealthy women

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Physically active men and women

You may qualify if:

  • BMI between 18 and 25 kg/m²
  • Non smoker
  • min of moderate physical activity or 75-150 min of intensive physical activity per week.
  • Written informed consent

You may not qualify if:

  • Iron metabolism disorders (i.e. genetic hemochromatosis, thalassemia, anemia)
  • Cardiovascular risks
  • Metabolic diseases (e.g.diabetes)
  • Use of non-steroidal anti-inflammatory drugs or aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rennes 2 - Laboratory "Movement, Sport and health Sciences"

Bruz, Brittany Region, 35170, France

Location

Related Publications (8)

  • Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.

    PMID: 25492375BACKGROUND
  • Peeling P, McKay AKA, Pyne DB, Guelfi KJ, McCormick RH, Laarakkers CM, Swinkels DW, Garvican-Lewis LA, Ross MLR, Sharma AP, Leckey JJ, Burke LM. Factors influencing the post-exercise hepcidin-25 response in elite athletes. Eur J Appl Physiol. 2017 Jun;117(6):1233-1239. doi: 10.1007/s00421-017-3611-3. Epub 2017 Apr 13.

    PMID: 28409396BACKGROUND
  • Heffernan SM, Horner K, De Vito G, Conway GE. The Role of Mineral and Trace Element Supplementation in Exercise and Athletic Performance: A Systematic Review. Nutrients. 2019 Mar 24;11(3):696. doi: 10.3390/nu11030696.

    PMID: 30909645BACKGROUND
  • Roecker L, Meier-Buttermilch R, Brechtel L, Nemeth E, Ganz T. Iron-regulatory protein hepcidin is increased in female athletes after a marathon. Eur J Appl Physiol. 2005 Dec;95(5-6):569-71. doi: 10.1007/s00421-005-0055-y. Epub 2005 Oct 26.

    PMID: 16249921BACKGROUND
  • Sim M, Garvican-Lewis LA, Cox GR, Govus A, McKay AKA, Stellingwerff T, Peeling P. Iron considerations for the athlete: a narrative review. Eur J Appl Physiol. 2019 Jul;119(7):1463-1478. doi: 10.1007/s00421-019-04157-y. Epub 2019 May 4.

    PMID: 31055680BACKGROUND
  • Mota JO, Tounian P, Guillou S, Pierre F, Membre JM. Estimation of the Burden of Iron Deficiency Anemia in France from Iron Intake: Methodological Approach. Nutrients. 2019 Sep 1;11(9):2045. doi: 10.3390/nu11092045.

    PMID: 31480641BACKGROUND
  • Loreal O, Cavey T, Bardou-Jacquet E, Guggenbuhl P, Ropert M, Brissot P. Iron, hepcidin, and the metal connection. Front Pharmacol. 2014 Jun 4;5:128. doi: 10.3389/fphar.2014.00128. eCollection 2014.

    PMID: 24926268BACKGROUND
  • Cavey T, Ropert M, de Tayrac M, Bardou-Jacquet E, Island ML, Leroyer P, Bendavid C, Brissot P, Loreal O. Mouse genetic background impacts both on iron and non-iron metals parameters and on their relationships. Biometals. 2015 Aug;28(4):733-43. doi: 10.1007/s10534-015-9862-8. Epub 2015 Jun 4.

    PMID: 26041486BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Erythrocytes and plasma samples

Study Officials

  • Frédéric DERBRE, PhD

    Laboratory of Movement, Sport and health Sciences (M2S)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

February 7, 2023

Primary Completion

April 14, 2024

Study Completion

April 14, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations