Healthy Young MenMETALEXONCT05718752
Characterization of the Plasma Metallomic Profile to Acute Exercise in Healthy Men and Women (METALEXO)
An observational study of Healthy Young Men and Healthy Young Women, run by University of Rennes 2 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Men, Healthy Young Women
- What is being tested?
- Maximal incremental exercise test and 30-min submaximal exercise test
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 14 Apr 2024
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Physically active men and women
Who may be able to join
- BMI between 18 and 25 kg/m²
- Non smoker
- 150-300 min of moderate physical activity or 75-150 min of intensive physical activity per week.
- Written informed consent
Who cannot join
- 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
- Simultaneous participation in another research involving the human person or having recently participated in another research for which the exclusion period has not been completed.
Trial locations and contacts
1 site in 1 country.
France1 site
University Rennes 2 - Laboratory "Movement, Sport and health Sciences"
Bruz, Brittany Region, 35170
About this study
Official title: Characterization of the Metallome Fingerprint to Acute Intense Exercise: a Pilot Study on 40 Healthy Men and Women.
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.
Read the detailed description
Numerous trace element metals play an essential role in energy metabolism including magnesium, zinc or manganese (Heffernan et al., 2019). Elite men and women athletes with high energy demands consequently needs to compensate with food or drink intakes the lost and/or body misdistribution of these trace element metals during physical exercise. Trace element metals and their interactions in metabolic processes can play an important role in physical performance. However, the modulation of their plasma availability in response to acute exercise remains poorly understood (Heffernan et al., 2019). The Inductively Coupled Plasma Mass Spectrometry (ICP-MS) constitutes an efficient technology to detect and quantify all trace element metals in plasma and erythrocytes to answer this question.
Among the different trace element metals, iron is one of the most studied during the last 30 years. Iron is indeed an essential component of hemoglobin and myoglobin allowing an optimal oxygen delivery to organs, especially to skeletal muscle under contraction. Iron also plays a major role in the mitochondrial respiratory chain, as well as in the activity of numerous enzymes. Iron deficiency, especially in plasma iron availability, exerts deleterious consequences on sport performance by promoting iron deficiency anemia. Endurance athletes frequently exhibit iron deficiency (Sim et al., 2019), but the latter could also impact non-athletic populations, especially women (Mota et al., 2019). Disorders in iron metabolism during intense exercise could depend on several factors including hyperhecpidinemia (Roecker et al., 2005). High plasma hepcidin levels indeed contributes to reduction in plasma iron availability classically observed in elite athletes. Moreover, intravascular hemolysis combined to urinary, gastro-intestinal and/or sweat iron lost, could be also observed during prolonged intense exercise (Peeling et al., 2017). All together, these factors can directly impact functional capacities during physical exercise. Interestingly, 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 (Loréal et al., 2014; Cavey et al., 2015). During intense physical exercise, the non-ferrous metals could thus directly or indirectly play a role in the modulation of iron import, storage or export in various kind of cells, and so functional capacities.
In this context, the pilot clinical study aims to characterize the plasma metallomic profile in response to an acute intense exercise in healthy men and women. All the volunteers (n=40) will perform 3 visits in the M2S lab: 1) an inclusion visit including anthropometric measures, dietary and physical activity surveys, 2) a second visit to perform the incremental cycling test, 3) a last visit to perform metabolic measures during a 30-min intense exercise (i.e. 90% of mechanical power at anaerobic threshold). Blood samples will be collected before, at the end of this intense exercise, and after 3 hours of recovery to determine in plasma systemic iron metabolism parameters and the concentrations of 29 non-ferrous metals.
- Conditions
- Healthy Young Men, Healthy Young Women
- Being tested
- Maximal incremental exercise test, 30-min submaximal exercise test
- Keywords
- Maximal oxygen consumption, Physical performance, Metallomic profile, Iron metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal incremental exercise testDiagnostic test
Gas exchange are measured during all the test on ergocycle until oxygen consumption reach its maximum value
30-min submaximal exercise testDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy men | no intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: 30-min submaximal exercise test | |
| Healthy women | no intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: 30-min submaximal exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 3
Secondary outcomes (4)
Plasma non-ferrous metals levels
Plasma concentrations of 29 non-ferrous metals will be determined before, just after the 30-min continuous ergocycle test and after 3 hours of recovery. Measurements will be performed using Inductively Coupled Plasma Mass Spectrometry (ICP/MS). A heat map will be performed to compare the hierarchical cluster analysis of plasma non-ferrous metals concentrations before and after physical exercise.
Measured: Week 3
Plasma metallome fingerprint
Univariate linear regression will be determined to explore interactions between plasma concentrations of iron and non-ferrous metals.
Measured: Week 3
Erythrocyte non-ferrous metals levels
Erythrocyte concentrations of 29 non-ferrous metals will be determined before, just after the 30-min continuous ergocycle test and after 3 hours of recovery. Measurements will be performed using Inductively Coupled Plasma Mass Spectrometry (ICP/MS).
Measured: Week 3
Erythrocyte metallome fingerprint
Univariate linear regression will be determined to explore interactions between erythrocyte concentrations of iron and non-ferrous metals.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start7 Feb 2023
- Primary completion14 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy Young MenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric Derbré, University of Rennes 2
- Investigators
- Frédéric DERBRE, PhD, Principal investigator, Laboratory of Movement, Sport and health Sciences (M2S)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718752
- Sponsor's protocol ID
- 2022-A02314-39
- Acronym
- METALEXO
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25492375Peeling 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.
PubMed 28409396Heffernan 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.
PubMed 30909645Roecker 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.
PubMed 16249921Sim 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.
PubMed 31055680Mota 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.
PubMed 31480641Loreal 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.
PubMed 24926268Cavey 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.
PubMed 26041486
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Metallome Fingerprint to Acute Intense Exercise: a Pilot Study on 40 Healthy Men and Women.
- ClinicalTrials.gov ID
- NCT05718752
- Acronym / sponsor ID
- METALEXO / 2022-A02314-39
- Conditions
- Healthy Young Men, Healthy Young Women
- Keywords
- Maximal oxygen consumption, Physical performance, Metallomic profile, Iron metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 8 Feb 2023 (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.
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.
Detailed description
Numerous trace element metals play an essential role in energy metabolism including magnesium, zinc or manganese (Heffernan et al., 2019). Elite men and women athletes with high energy demands consequently needs to compensate with food or drink intakes the lost and/or body misdistribution of these trace element metals during physical exercise. Trace element metals and their interactions in metabolic processes can play an important role in physical performance. However, the modulation of their plasma availability in response to acute exercise remains poorly understood (Heffernan et al., 2019). The Inductively Coupled Plasma Mass Spectrometry (ICP-MS) constitutes an efficient technology to detect and quantify all trace element metals in plasma and erythrocytes to answer this question.
Among the different trace element metals, iron is one of the most studied during the last 30 years. Iron is indeed an essential component of hemoglobin and myoglobin allowing an optimal oxygen delivery to organs, especially to skeletal muscle under contraction. Iron also plays a major role in the mitochondrial respiratory chain, as well as in the activity of numerous enzymes. Iron deficiency, especially in plasma iron availability, exerts deleterious consequences on sport performance by promoting iron deficiency anemia. Endurance athletes frequently exhibit iron deficiency (Sim et al., 2019), but the latter could also impact non-athletic populations, especially women (Mota et al., 2019). Disorders in iron metabolism during intense exercise could depend on several factors including hyperhecpidinemia (Roecker et al., 2005). High plasma hepcidin levels indeed contributes to reduction in plasma iron availability classically observed in elite athletes. Moreover, intravascular hemolysis combined to urinary, gastro-intestinal and/or sweat iron lost, could be also observed during prolonged intense exercise (Peeling et al., 2017). All together, these factors can directly impact functional capacities during physical exercise. Interestingly, 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 (Loréal et al., 2014; Cavey et al., 2015). During intense physical exercise, the non-ferrous metals could thus directly or indirectly play a role in the modulation of iron import, storage or export in various kind of cells, and so functional capacities.
In this context, the pilot clinical study aims to characterize the plasma metallomic profile in response to an acute intense exercise in healthy men and women. All the volunteers (n=40) will perform 3 visits in the M2S lab: 1) an inclusion visit including anthropometric measures, dietary and physical activity surveys, 2) a second visit to perform the incremental cycling test, 3) a last visit to perform metabolic measures during a 30-min intense exercise (i.e. 90% of mechanical power at anaerobic threshold). Blood samples will be collected before, at the end of this intense exercise, and after 3 hours of recovery to determine in plasma systemic iron metabolism parameters and the concentrations of 29 non-ferrous metals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy men | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: 30-min submaximal exercise testno intervention |
| Healthy women | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: 30-min submaximal exercise testno intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Physically active men and women
Key inclusion criteria (4 listed)
- BMI between 18 and 25 kg/m²
- Non smoker
- 150-300 min of moderate physical activity or 75-150 min of intensive physical activity per week.
- Written informed consent
Key exclusion criteria (5 listed)
- 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
- Simultaneous participation in another research involving the human person or having recently participated in another research for which the exclusion period has not been completed.
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 |
|---|---|---|
| Maximal incremental exercise testGas exchange are measured during all the test on ergocycle until oxygen consumption reach its maximum value | Diagnostic test | Healthy men, Healthy women |
| 30-min submaximal exercise testA 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 | Diagnostic test | Healthy men, Healthy women |
Primary outcome
Plasma iron availability
Time frame: Week 3
Serum iron levels and transferrin saturation will be determined before, just after the 30-min continuous ergocycle test and after 3 hours of recovery
4 secondary outcomes
Plasma non-ferrous metals levels
Time frame: Week 3
Plasma metallome fingerprint
Time frame: Week 3
Erythrocyte non-ferrous metals levels
Time frame: Week 3
Erythrocyte metallome fingerprint
Time frame: Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 25492375Cleland 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.
- Background: PubMed 28409396Peeling 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.
- Background: PubMed 30909645Heffernan 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.
- Background: PubMed 16249921Roecker 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.
- Background: PubMed 31055680Sim 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.
- Background: PubMed 31480641Mota 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.
- Background: PubMed 24926268Loreal 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.
- Background: PubMed 26041486Cavey 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.
- 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.
Frédéric DERBRE, PhD principal investigator
Laboratory of Movement, Sport and health Sciences (M2S)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Young Men and Healthy Young Women, run by University of Rennes 2 at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 28 Jun 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma iron availability (time frame: Week 3). 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 NCT05718752, which also lists 8 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 28 Jun 2024.