Sub-elite Football PlayersNCT05061394
Changes in Peak Fat Oxidation and Aerobic Fitness During Pre-season in Sub-elite Football Players
An observational study of Sub-elite Football Players, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Cross-sectional studies clearly demonstrate that the maximal fat oxidation (MFO, onwards referred to as peak fat oxidation, PFO) and the intensity at which it occurs (Fatmax) are higher in trained compared with untrained men and women (Maunder et al. 2018; Nordby et al. 2006; Lima-Silva et al. 2010). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Sub-elite Football Players
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2021to 30 May 2021
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Study population: Sub-elite football players from three local football clubs in the Copenhagen region
Who may be able to join
- Sub-elite football player
Who cannot join
- Cardiovascular and/or metabolic disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Cross-sectional studies clearly demonstrate that the maximal fat oxidation (MFO, onwards referred to as peak fat oxidation, PFO) and the intensity at which it occurs (Fatmax) are higher in trained compared with untrained men and women (Maunder et al. 2018; Nordby et al. 2006; Lima-Silva et al. 2010). Furthermore, a recent study in endurance-trained males have shown a relationship between PFO and performance in an Ironman triathlon (Frandsen et al. 2017). The interest of PFO and Fatmax in endurance sports is centered on the speculation that increased fat oxidation rates during exercise would benefit endurance performance (> 4 hours) due to a glycogen sparing effect. Furthermore, it is speculated that the high amount of low-intensity training (70-80%), as seen with elite endurance athletes, might be essential in order to increase the fat oxidation capacity. However, when PFO is compared across an athletic population, football players have similar values as endurance-trained athletes (Randell et al. 2016; Randell et al. 2019; Frandsen et al. 2017), which is somewhat surprising when the different training regimes are considered.
It is noteworthy that the variations in PFO in various types of athletes and football players are considerable (Randell et al. 2016). However, different playing position in football has different work requirements, thus it might be that some of the variation seen in PFO could be related to the different playing position.
To our knowledge, no study has previously looked at the variations in fat oxidation capacity before and after a training period in athletes. Therefore, the aim of the present study is to investigate changes in peak fat oxidation and aerobic fitness during a pre-season training period in sub-elite football players. A secondary aim is to investigate if the changes are related to specific playing positions on the field. The overall hypothesis is that a pre-season training period would increase the fat oxidation capacity and aerobic fitness, and that the changes are related to specific player positions.
Read the detailed description
Three sub-elite football teams in the Copenhagen area will be recruited for the study. The study will include two visits to our laboratory and field tests during the pre-season.
Before the participants volunteered to participate and signed a written informed consent form, the participants received both written and oral information about the content and possible risks associated with the study.
The participants arrived at the laboratory after an overnight fast (from latest 10pm). Furthermore, the participants were asked to avoid strenuous exercise 48 hours prior to the test day and eat a habitual diet, which had to be replicated before the second visit.
Testing at our laboratory includes:
- Measurements of height and weight anthropometry.
- Measurement of body composition using a Dual-energy X-ray absorptiometry (DXA) scan.
- Measurement of VO2max using a non-exercise testing method based on seismocardiography.
- Collection of a 15 ml resting venous blood sample for measurements of resting levels of hormones, metabolites and lipids in the blood plasma.
- Measurement of PFO and Fatmax during a graded submaximal running test on a motor driven treadmill.
- Measurement of VO2max on a motor driven treadmill.
- A questionnaire regarding previous and current football level, numbers of active years, playing position etc.
Procedure and analysis:
DXA scanning: The participants will be placed in the supine position in the DXA scanner (Lunar iDXA, GE Healthcare) after voiding and while wearing minimal clothing.
Blood samples: The blood samples will be collected from the vein cubiti medialis in the forearm. The blood will be sampled in iced BD vacutainers (5 mL Aprotinin, 4 mL EDTA and 2 mL Lithium Heparin) and immediately centrifuged at 4000 g for 10 minutes at 4⁰C (Rotina 380R, Hettich). The plasma will be collected and stored at -80⁰C for later analyzes of resting levels of metabolites, lipids and hormones.
The concentrations of hemoglobin, hematocrit, glucose and lactate will be immediately analyzed though sampling of 2 mL blood in a specialized syringe (safePICO Aspirator, Radiometer) and using an automatic analyzer (ABL800 Flex, Radiometer).
Exercise testing: The participants will perform a graded exercise test on a motor driven treadmill (Woodway Pro XL, Woodway USA Inc) with breath-by-breath measurements of pulmonary gas exchange by an automated online system (Quark CPET, Cosmed) throughout the test.
The protocol is adapted from Randell et al. 2019 with minor adjustments.
The protocol will start with a resting period with the participant sitting on a chair on the treadmill for 5 min. The exercise will hereafter commence at 6 km/h with a 1% incline for 5 minutes, where after the speed will be increased with 2 km/h every 3 minutes until the respiratory exchange ratio exceed 1.00. Subsequently, the incline will increase 2% every minutes until voluntary exhaustion, while the speed is held constant.
Participants will be wearing a chest strapped heart rate monitor (Garmin HRM-Tri, Garmin Forerunner 735XT, Garmin Ltd) with continuous heart rate measures during the test. Furthermore the participants, will be asked about perceived exhaustion on the 6-20 Borg scale directly following exhaustion.
The field tests will include three Yo-Yo intermittent Recovery level 2 test (YYIR2) and session-RPE (rate of perceived exertion (1-10 scale) for every training session. The YYIR2 will be scheduled with one in the second week of training, one midway and one during the last week of training before the start of the competitive season.
Statistical analysis:
All data will be checked for normal distribution (Shapiro-Wilk test) and equal variance (Brown- Forsythe test). The significant level is p<0.05.
Systematic differences in PFO, aerobic fitness, body composition and resting pre exercise blood values before and after the pre-season training period will be analyzed with a paired t test.
Pearson correlation analysis will be conducted with relevant resting pre exercise blood values and PFO, aerobic fitness and body composition in order to analyze association in possible differences between pre and post testing. Additionally, relevant resting pre exercise blood values will furthermore be analyzed with a coefficient of variation (CV%) analysis in order to look at the day-to-day variation.
In order to answer our secondary aim, a two-way ANOVA with repeated measures will be applied to analyze any effect of time and specific player position group in PFO and aerobic fitness. A post-hoc Sidak's multiple comparisons test will be applied when a significant effect of time or specific player positon group is found.
The project was approved by the Science Ethical commitee of the greater region of Copenhagen (H-20019103) the 3rd of July 2020. The protocol of the study adhered to the principles of the Helsinki declaration
- Conditions
- Sub-elite Football Players
- Keywords
- Peak fat oxidation, Aerobic fitness, Football players, Treadmill running, Fatmax, Pre-season training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Second division football players | Players competing in the third best league in Denmark | |
| "Danmarkserien" football players | Players competing in the fourth best league in Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Peak Fat Oxidation During Pre-season in Sub-elite Football Players
Peak Fat Oxidation (PFO) will be measured before and after pre-season in Sub-elite Football players, and pulmonary gas exchange will be measured during the treadmill running protocol as previously described. The fat oxidation rates will be calculated using the stoichiometric equations described by Frayn, with the assumption that urinary nitrogen excretion is negligible: Fat oxidation (g⋅min-1) = (1.67 ⋅ VȮ2) - (1.67 ⋅ V̇CO2). A 3nd-degree polynomial regression will be applied to determine PFO and the intensity at which it occurs (Fatmax) for each test individually. Changes in PFO from baseline and after 8 week pre-season will be measured and reported.
Measured: From January until April
We will measure Aerobic Fitness before and after a Pre-season in Sub-elite Football Players
Aerobic Fitness will be measured before and pre-season in Sub-elite Football players, and pulmonary gas exchange measurements will be measured during the treadmill running protocol as previously described. VO2max will be reported both as an absolute value (ml/min) and relative to body-weight (ml/min/kg). The VO2max is determined as the highest value measured over consecutive 30 seconds. Changes in VO2max from baseline and after 8 week pre-season will be measured and reported.
Measured: From January until April
Secondary outcomes (2)
To investigate if the possible changes in Peak Fat Oxidation are related to specific playing positions on the field
The football players are divided into five different playing position (Goalkeeper, Center backs, Wingers, Midfielder, Striker) based on a questionnaire. The possible changes in the measured Peak Fat Oxidation from baseline to post pre-season will be compared between the different playing positions.
Measured: From January until April
To investigate if the possible changes Aerobic Fitness are related to specific playing positions on the field
The football players are divided into five different playing position (Goalkeeper, Center backs, Wingers, Midfielder, Striker) based on a questionnaire. The possible changes in the measured Aerobic Fitness from baseline to post pre-season will be compared between the different playing positions.
Measured: From January until April
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start4 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sub-elite Football PlayersStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- VentriJect ApS, University of Southern Denmark
- Responsible party
- Principal investigator, Jørn Wulff Helge, University of Copenhagen
- Investigators
- Jørn W Helge, Professor, Principal investigator, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061394
- Sponsor's protocol ID
- VentriJect Football Study
- Status last verified
- Feb 2024
- First submitted
- 10 Mar 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Randell RK, Carter JM, Jeukendrup AE, Lizarraga MA, Yanguas JI, Rollo I. Fat Oxidation Rates in Professional Soccer Players. Med Sci Sports Exerc. 2019 Aug;51(8):1677-1683. doi: 10.1249/MSS.0000000000001973.
PubMed 30845048Randell RK, Rollo I, Roberts TJ, Dalrymple KJ, Jeukendrup AE, Carter JM. Maximal Fat Oxidation Rates in an Athletic Population. Med Sci Sports Exerc. 2017 Jan;49(1):133-140. doi: 10.1249/MSS.0000000000001084.
PubMed 27580144Maunder E, Plews DJ, Kilding AE. Contextualising Maximal Fat Oxidation During Exercise: Determinants and Normative Values. Front Physiol. 2018 May 23;9:599. doi: 10.3389/fphys.2018.00599. eCollection 2018.
PubMed 29875697Nordby P, Saltin B, Helge JW. Whole-body fat oxidation determined by graded exercise and indirect calorimetry: a role for muscle oxidative capacity? Scand J Med Sci Sports. 2006 Jun;16(3):209-14. doi: 10.1111/j.1600-0838.2005.00480.x.
PubMed 16643200Lima-Silva AE, Bertuzzi RC, Pires FO, Gagliardi JF, Barros RV, Hammond J, Kiss MA. Relationship between training status and maximal fat oxidation rate. J Sports Sci Med. 2010 Mar 1;9(1):31-5. eCollection 2010.
PubMed 24149383Frandsen J, Vest SD, Larsen S, Dela F, Helge JW. Maximal Fat Oxidation is Related to Performance in an Ironman Triathlon. Int J Sports Med. 2017 Nov;38(13):975-982. doi: 10.1055/s-0043-117178. Epub 2017 Oct 19.
PubMed 29050040
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Peak Fat Oxidation and Aerobic Fitness During Pre-season in Sub-elite Football Players
- ClinicalTrials.gov ID
- NCT05061394
- Acronym / sponsor ID
- VentriJect Football Study
- Conditions
- Sub-elite Football Players
- Keywords
- Peak fat oxidation, Aerobic fitness, Football players, Treadmill running, Fatmax, Pre-season training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- VentriJect ApS, University of Southern Denmark
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 29 Sep 2021 (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.
Cross-sectional studies clearly demonstrate that the maximal fat oxidation (MFO, onwards referred to as peak fat oxidation, PFO) and the intensity at which it occurs (Fatmax) are higher in trained compared with untrained men and women (Maunder et al. 2018; Nordby et al. 2006; Lima-Silva et al. 2010). Furthermore, a recent study in endurance-trained males have shown a relationship between PFO and performance in an Ironman triathlon (Frandsen et al. 2017). The interest of PFO and Fatmax in endurance sports is centered on the speculation that increased fat oxidation rates during exercise would benefit endurance performance (> 4 hours) due to a glycogen sparing effect. Furthermore, it is speculated that the high amount of low-intensity training (70-80%), as seen with elite endurance athletes, might be essential in order to increase the fat oxidation capacity. However, when PFO is compared across an athletic population, football players have similar values as endurance-trained athletes (Randell et al. 2016; Randell et al. 2019; Frandsen et al. 2017), which is somewhat surprising when the different training regimes are considered.
It is noteworthy that the variations in PFO in various types of athletes and football players are considerable (Randell et al. 2016). However, different playing position in football has different work requirements, thus it might be that some of the variation seen in PFO could be related to the different playing position.
To our knowledge, no study has previously looked at the variations in fat oxidation capacity before and after a training period in athletes. Therefore, the aim of the present study is to investigate changes in peak fat oxidation and aerobic fitness during a pre-season training period in sub-elite football players. A secondary aim is to investigate if the changes are related to specific playing positions on the field. The overall hypothesis is that a pre-season training period would increase the fat oxidation capacity and aerobic fitness, and that the changes are related to specific player positions.
Detailed description
Three sub-elite football teams in the Copenhagen area will be recruited for the study. The study will include two visits to our laboratory and field tests during the pre-season.
Before the participants volunteered to participate and signed a written informed consent form, the participants received both written and oral information about the content and possible risks associated with the study.
The participants arrived at the laboratory after an overnight fast (from latest 10pm). Furthermore, the participants were asked to avoid strenuous exercise 48 hours prior to the test day and eat a habitual diet, which had to be replicated before the second visit.
Testing at our laboratory includes:
- Measurements of height and weight anthropometry.
- Measurement of body composition using a Dual-energy X-ray absorptiometry (DXA) scan.
- Measurement of VO2max using a non-exercise testing method based on seismocardiography.
- Collection of a 15 ml resting venous blood sample for measurements of resting levels of hormones, metabolites and lipids in the blood plasma.
- Measurement of PFO and Fatmax during a graded submaximal running test on a motor driven treadmill.
- Measurement of VO2max on a motor driven treadmill.
- A questionnaire regarding previous and current football level, numbers of active years, playing position etc.
Procedure and analysis:
DXA scanning: The participants will be placed in the supine position in the DXA scanner (Lunar iDXA, GE Healthcare) after voiding and while wearing minimal clothing.
Blood samples: The blood samples will be collected from the vein cubiti medialis in the forearm. The blood will be sampled in iced BD vacutainers (5 mL Aprotinin, 4 mL EDTA and 2 mL Lithium Heparin) and immediately centrifuged at 4000 g for 10 minutes at 4⁰C (Rotina 380R, Hettich). The plasma will be collected and stored at -80⁰C for later analyzes of resting levels of metabolites, lipids and hormones.
The concentrations of hemoglobin, hematocrit, glucose and lactate will be immediately analyzed though sampling of 2 mL blood in a specialized syringe (safePICO Aspirator, Radiometer) and using an automatic analyzer (ABL800 Flex, Radiometer).
Exercise testing: The participants will perform a graded exercise test on a motor driven treadmill (Woodway Pro XL, Woodway USA Inc) with breath-by-breath measurements of pulmonary gas exchange by an automated online system (Quark CPET, Cosmed) throughout the test.
The protocol is adapted from Randell et al. 2019 with minor adjustments.
The protocol will start with a resting period with the participant sitting on a chair on the treadmill for 5 min. The exercise will hereafter commence at 6 km/h with a 1% incline for 5 minutes, where after the speed will be increased with 2 km/h every 3 minutes until the respiratory exchange ratio exceed 1.00. Subsequently, the incline will increase 2% every minutes until voluntary exhaustion, while the speed is held constant.
Participants will be wearing a chest strapped heart rate monitor (Garmin HRM-Tri, Garmin Forerunner 735XT, Garmin Ltd) with continuous heart rate measures during the test. Furthermore the participants, will be asked about perceived exhaustion on the 6-20 Borg scale directly following exhaustion.
The field tests will include three Yo-Yo intermittent Recovery level 2 test (YYIR2) and session-RPE (rate of perceived exertion (1-10 scale) for every training session. The YYIR2 will be scheduled with one in the second week of training, one midway and one during the last week of training before the start of the competitive season.
Statistical analysis:
All data will be checked for normal distribution (Shapiro-Wilk test) and equal variance (Brown- Forsythe test). The significant level is p<0.05.
Systematic differences in PFO, aerobic fitness, body composition and resting pre exercise blood values before and after the pre-season training period will be analyzed with a paired t test.
Pearson correlation analysis will be conducted with relevant resting pre exercise blood values and PFO, aerobic fitness and body composition in order to analyze association in possible differences between pre and post testing. Additionally, relevant resting pre exercise blood values will furthermore be analyzed with a coefficient of variation (CV%) analysis in order to look at the day-to-day variation.
In order to answer our secondary aim, a two-way ANOVA with repeated measures will be applied to analyze any effect of time and specific player position group in PFO and aerobic fitness. A post-hoc Sidak's multiple comparisons test will be applied when a significant effect of time or specific player positon group is found.
The project was approved by the Science Ethical commitee of the greater region of Copenhagen (H-20019103) the 3rd of July 2020. The protocol of the study adhered to the principles of the Helsinki declaration
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second division football players | – | –Players competing in the third best league in Denmark |
| "Danmarkserien" football players | – | –Players competing in the fourth best league in Denmark |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sub-elite football players from three local football clubs in the Copenhagen region
Key inclusion criteria (1 listed)
- Sub-elite football player
Key exclusion criteria (1 listed)
- Cardiovascular and/or metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Peak Fat Oxidation During Pre-season in Sub-elite Football Players
Time frame: From January until April
Peak Fat Oxidation (PFO) will be measured before and after pre-season in Sub-elite Football players, and pulmonary gas exchange will be measured during the treadmill running protocol as previously described. The fat oxidation rates will be calculated using the stoichiometric equations described by Frayn, with the assumption that urinary nitrogen excretion is negligible: Fat oxidation (g⋅min-1) = (1.67 ⋅ VȮ2) - (1.67 ⋅ V̇CO2). A 3nd-degree polynomial regression will be applied to determine PFO and the intensity at which it occurs (Fatmax) for each test individually. Changes in PFO from baseline and after 8 week pre-season will be measured and reported.
We will measure Aerobic Fitness before and after a Pre-season in Sub-elite Football Players
Time frame: From January until April
Aerobic Fitness will be measured before and pre-season in Sub-elite Football players, and pulmonary gas exchange measurements will be measured during the treadmill running protocol as previously described. VO2max will be reported both as an absolute value (ml/min) and relative to body-weight (ml/min/kg). The VO2max is determined as the highest value measured over consecutive 30 seconds. Changes in VO2max from baseline and after 8 week pre-season will be measured and reported.
2 secondary outcomes
To investigate if the possible changes in Peak Fat Oxidation are related to specific playing positions on the field
Time frame: From January until April
To investigate if the possible changes Aerobic Fitness are related to specific playing positions on the field
Time frame: From January until April
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 15 Feb 2024.
- Background: PubMed 30845048Randell RK, Carter JM, Jeukendrup AE, Lizarraga MA, Yanguas JI, Rollo I. Fat Oxidation Rates in Professional Soccer Players. Med Sci Sports Exerc. 2019 Aug;51(8):1677-1683. doi: 10.1249/MSS.0000000000001973.
- Background: PubMed 27580144Randell RK, Rollo I, Roberts TJ, Dalrymple KJ, Jeukendrup AE, Carter JM. Maximal Fat Oxidation Rates in an Athletic Population. Med Sci Sports Exerc. 2017 Jan;49(1):133-140. doi: 10.1249/MSS.0000000000001084.
- Background: PubMed 29875697Maunder E, Plews DJ, Kilding AE. Contextualising Maximal Fat Oxidation During Exercise: Determinants and Normative Values. Front Physiol. 2018 May 23;9:599. doi: 10.3389/fphys.2018.00599. eCollection 2018.
- Background: PubMed 16643200Nordby P, Saltin B, Helge JW. Whole-body fat oxidation determined by graded exercise and indirect calorimetry: a role for muscle oxidative capacity? Scand J Med Sci Sports. 2006 Jun;16(3):209-14. doi: 10.1111/j.1600-0838.2005.00480.x.
- Background: PubMed 24149383Lima-Silva AE, Bertuzzi RC, Pires FO, Gagliardi JF, Barros RV, Hammond J, Kiss MA. Relationship between training status and maximal fat oxidation rate. J Sports Sci Med. 2010 Mar 1;9(1):31-5. eCollection 2010.
- Background: PubMed 29050040Frandsen J, Vest SD, Larsen S, Dela F, Helge JW. Maximal Fat Oxidation is Related to Performance in an Ironman Triathlon. Int J Sports Med. 2017 Nov;38(13):975-982. doi: 10.1055/s-0043-117178. Epub 2017 Oct 19.
- Individual participant dataSharing planned: No
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.
Jørn W Helge, Professor principal investigator
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
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 Sub-elite Football Players, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 1 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 15 Feb 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 Denmark. 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?
Changes in Peak Fat Oxidation During Pre-season in Sub-elite Football Players (time frame: From January until April). The study lists 2 primary outcomes in all. 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 NCT05061394, which also lists 6 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 15 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.