HealthyBREATHE-CNCT07233707
Load and Hold: Impact of 7-Day Creatine Monohydrate Loading on Breath-Hold Cycling Performance
A study testing Creatine Monohydrate in people with Healthy, run by Harokopio University at 1 site in Greece.
Trial summary
The present study aims to investigate the effects of creatine monohydrate supplementation on maximal breath-hold exercise performance on a bicycle ergometer in trained breath-hold divers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- 24 Jul 2025to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy trained breath-hold divers (with at least one year of experience in dynamic breath-hold diving training and competition) who haven't been supplementing with creatine monohydrate for at least the past 6 weeks prior to the start of the study
Who cannot join
- breath-hold divers with less than 1 year of experience in dynamic breath-hold training and competition
- breath-hold divers with any acute or chronic medical conditions
- breath-hold divers that supplement with creatine monohydrate or have been supplementing with creatine monohydrate in the past 6 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Creatine Monohydrate Supplementation on Breath-Hold Exercise Performance on a Bicycle Ergometer
The present study aims to investigate the effects of creatine monohydrate supplementation on maximal breath-hold exercise performance on a bicycle ergometer in trained breath-hold divers. The testing protocol is specifically designed to replicate the physiological demands and exercise intensity of a maximal dynamic breath-hold dive.
Creatine supplementation may improve breath-hold exercise capacity by acting as a rapid, anaerobic energy source that is independent of oxygen availability that does not generate fatigue-inducing metabolic byproducts. Furthermore, its intracellular buffering properties may help delay the onset of metabolic acidosis, thereby possibly prolonging muscular work under hypoxic conditions.
Read more
Therefore, the main questions the study aims to answer are:
- Can creatine monohydrate loading supplementation protocol improve breath-hold exercise performance by increasing total work (TW) and time to exhaustion (TTE)?
- Can it will increase lactate threshold and delay the onset of the metabolic acidosis?
Researchers will compare creatine monohydrate supplementation to a placebo (maltodextrin) to determine whether creatine improves maximal breath-hold exercise performance on a bicycle ergometer in trained breath-hold divers.
Participants will:
- Attend scheduled laboratory visits on 4 occasions (one for performing graded exercise test (GXT), one for familiarization with the breath-hold exercise (BHE) protocol, one for pre-supplementation BHE testing, one for post-supplementation BHE testing)
- Take creatine monohydrate or a placebo for 7 days (5g four times per day)
- Report any discomforts during supplementation period, log the type and frequency of their trainings 7 days prior to pre and post-supplementation testing, report everything they ate and drunk on the day prior to the pre and post-supplementation testing
Read the detailed description
Creatine is well known for its role in enhancing adenosine triphosphate (ATP) regeneration and therefore aiding in short high-intensity activities, improving work capacity and power output of skeletal muscle, and delaying the onset of muscle fatigue. However, research on creatine supplementation in endurance sports has yielded inconsistent results. Some studies in this field showed improved endurance performance, while others failed to demonstrate it, or even showed decrements in it. This variability may stem from different supplementation protocols or the wide range of protocols used for measuring performance. Additionally, the increase in body mass resulting from creatine's osmotic properties may negatively impact performance in weight-bearing sports. Another factor may be muscle fiber composition, as individuals who respond best to creatine supplementation typically have a higher proportion of type II muscle fibers, whereas endurance athletes usually predominantly possess type I fibers.
Breath-hold diving is the practice of diving underwater on a single breath. Sport disciplines in breath-hold diving can be divided into three categories: static breath-hold, depth disciplines and dynamic disciplines. Static breath-hold focus on holding the breath for the longest possible time, depth disciplines focus on reaching the greatest possible depth underwater, while dynamic disciplines focus on covering the greatest possible distance underwater on a single breath. These disciplines test diver's oxygen (O2) management, metabolic byproducts tolerance, movement efficiency and energy conservation. Some of the limitations in breath-hold diving include tolerance to fatigue-inducing metabolic byproducts, the buildup of carbon dioxide (CO2) and O2 availability. As dive time and the muscular activity increase, O2 levels decrease, and reliance on anaerobic metabolic pathway intensifies, leading to the accumulation of metabolic byproducts such as lactate. Therefore, divers, among other things, train to optimize O2 utilization, to delay metabolic acidosis onset, and to enhance tolerance to elevated levels of metabolic byproducts.
Although breath-hold diving may not be considered a high-intensity sport in terms of heart rate and movement speed, it involves a unique performance pattern that includes limited availability of O2 and triggers a shift to anaerobic metabolism. This shift is sustained over extended periods, requiring significant effort and endurance to maintain performance. It is important to highlight that no form of exercise is purely anaerobic or aerobic, and that all energy systems contribute to ATP re-synthesis. However, their contribution depends on the nature of the activity. So, even though the phosphocreatine system may not dominate when it comes to endurance sports, it can still buffer energy demands and therefore prevent early onset of fatigue. Therefore, the energy produced by creatine phosphate (CP) is used for ATP yield as long as possible and it was shown that even though contribution of CP is reduced between 100 and 200 meters of running sprint, the CP stores are depleted only at the end of 400 meters.
As breath-hold diving requires efficient O2 utilization and as body relies predominantly on anaerobic metabolism that leads to metabolic acidosis, efficient ATP production, O2 utilization and CO2 production are crucial. Creatine supplementation may offer benefits by providing efficient energy production and delaying the onset of metabolic acidosis. In addition, creatine has an ability to buffer acidity by accepting and neutralizing excess hydrogen ions that accumulate in the muscles as a byproduct of anaerobic metabolism.
Lactate threshold (LT) is defined as the point of the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be cleared. A higher LT allows athletes to sustain higher speeds or higher power outputs before the onset of fatigue. Breath-hold divers could also benefit from a higher LT because of the delayed buildup of anaerobic metabolism byproducts. In various strength-endurance test protocols, creatine supplementation was suggested to increase LT, by improving ATP regeneration and increasing muscle buffering capacity, as well as to improve performance measured by total work (TW), time to exhaustion (TTE) and power output. Still, some studies failed to show improved endurance performance and increased LT.
In addition, ventilatory threshold (VT) is defined as the point during exercise at which ventilation increases disproportionately to O2 consumption due to the need to exhale accumulated CO2. VT is closely related to LT because when lactate starts accumulating, hydrogen ions accumulate too, non-metabolic CO2 production increases and so does the ventilatory rate. Nelson et al (2000) observed a significant lengthening of the run distance to the VT in long distance runners on a graded exercise test (GTX) after creatine supplementation. Authors concluded that this alteration resulted in the body being able to perform sub-maximal workload at a lower O2 cost and reduced work by cardiovascular system measured by heart rate.
Creatine supplementation may enhance breath-hold exercise performance by serving as an anaerobic alactic source of energy. Additionally, creatine has intracellular buffering properties that can help delay the onset of metabolic acidosis, thereby extending the duration of muscle work under hypoxic conditions.
The breath-hold exercise will be performed on a bicycle ergometer at an intensity matched to the maximal dynamic breath-hold dive, using heart rate as the indicator. The protocol is designed to replicate the key metabolic demands of dynamic breath-hold dive by requiring muscle work under hypoxic conditions.
Participants' heart rate after the maximal dynamic breath-hold dive will be accessed at their pool training. Individual end-dive heart rate (HR) will be used as indicator of exercise intensity for designing an individual breath-hold testing protocol for each participant. Participants will perform GXT in the laboratory in order to find the corresponding resistance on the bicycle ergometer that will match their end-dive HR. Therefore, the resistance on the bicycle ergometer that will be used for the final pre and post-supplementation testing will be defined by end-dive HR and data from GXT. Final testing will include cycling on the stationary ergometer where participants will be asked to cover the longest possible distance on one breath. Main measurements will include: distance covered on one breath, time of the breath-hold, pre and post-test lactate from the earlobe and rating of perceived exertion.
- Conditions
- Healthy
- Being tested
- Creatine Monohydrate, Placebo Control
- Keywords
- breath-hold exercise performance, creatine monohydrate loading, supplementation, bicycle ergometer, ergogenic aid, anaerobic endurance performance, nutritional intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine monohydrate 7-day loading phase
Placebo ControlDietary supplement
20 grams of maltodextrin per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate (CM) group | Experimental | CM group will receive 20 grams of creatine monohydrate per day for 7 days Receives: Dietary Supplement: Creatine Monohydrate |
| Placebo (PL) group | Placebo comparator | PL group will receive 20 grams of maltodextrin per day for 7 days Receives: Dietary Supplement: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Work
Performance will be evaluated based on two parameters, one of which is Total Work (TW). TW will represent distance covered on the bicycle ergometer on the maximum breath-hold exercise attempt. It will be measured on the bicycle ergometer Monark 839 E and expressed in meters.
Measured: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Time to Exhaustion
Performance will be evaluated based on two parameters, one of which is Time to Exhaustion (TTE). TTE will represent duration of the breath-hold during the maximum breath-hold exercise attempt. It will be measured on the bicycle ergometer Monark 839 E and expressed in seconds.
Measured: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Lactate accumulation
Lactate accumulation (the difference between lactate concentration in peripheral circulation immediately after exercise and that measured three minutes before exercise) will represent an objective indicator of fatigue. It will be measured from the earlobe using Lactate Scout 4 device, before and after maximum breath-hold exercise attempt, on both pre and post supplementation testing.
Measured: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Secondary outcomes (2)
Rating of Perceived Exertion
The Rating of Perceived Exertion (RPE) will be used as a subjective measure of fatigue. Immediately after maximum breath-hold exercise attempt, participants will report their perceived level of effort using the Borg Scale. They will provide separate ratings for overall breath-hold effort and for muscle strain.
Measured: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Change in Lean Body Mass
Lean Body Mass change will be assessed by DXA scan.
Measured: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start24 Jul 2025
- Primary completion26 Nov 2025 (estimated)
- Study completion26 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Belgrade
- Responsible party
- Principal investigator, Tzortzis Nomikos, Harokopio University
- Investigators
- Natalija Kurmazovic, Master of Science, Principal investigator, Faculty of Pharmacy, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233707
- Sponsor's protocol ID
- 3301/21-07-2025
- Acronym
- BREATHE-C
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nelson AG, Day R, Glickman-Weiss EL, Hegsted M, Kokkonen J, Sampson B. Creatine supplementation alters the response to a graded cycle ergometer test. Eur J Appl Physiol. 2000 Sep;83(1):89-94. doi: 10.1007/s004210000244.
PubMed 11072779McNaughton LR, Dalton B, Tarr J. The effects of creatine supplementation on high-intensity exercise performance in elite performers. Eur J Appl Physiol Occup Physiol. 1998 Aug;78(3):236-40. doi: 10.1007/s004210050413.
PubMed 9721002Furtado ETF, Oliveira JPL, Pereira ISB, Veiga EP, Silva SFD, Abreu WC. Short term creatine loading improves strength endurance even without changing maximal strength, RPE, fatigue index, blood lactate, and mode state. An Acad Bras Cienc. 2024 May 10;96(2):e20230559. doi: 10.1590/0001-3765202420230559. eCollection 2024.
PubMed 38747788Lee S, Hong G, Park W, Lee J, Kim N, Park H, Park J. The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise. Phys Act Nutr. 2020 Mar 31;24(1):29-36. doi: 10.20463/pan.2020.0006.
PubMed 32408412Oliver JM, Joubert DP, Martin SE, Crouse SF. Oral creatine supplementation's decrease of blood lactate during exhaustive, incremental cycling. Int J Sport Nutr Exerc Metab. 2013 Jun;23(3):252-8. doi: 10.1123/ijsnem.23.3.252. Epub 2012 Nov 19.
PubMed 23164647Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414.
PubMed 19885119Hirvonen J, Nummela A, Rusko H, Rehunen S, Harkonen M. Fatigue and changes of ATP, creatine phosphate, and lactate during the 400-m sprint. Can J Sport Sci. 1992 Jun;17(2):141-4.
PubMed 1324108RodrIguez-Zamora L, Engan HK, Lodin-Sundstrom A, Schagatay F, Iglesias X, Rodriguez FA, Schagatay E. Blood lactate accumulation during competitive freediving and synchronized swimming. Undersea Hyperb Med. 2018 Jan-Feb;45(1):55-63.
PubMed 29571233Cooper R, Naclerio F, Allgrove J, Jimenez A. Creatine supplementation with specific view to exercise/sports performance: an update. J Int Soc Sports Nutr. 2012 Jul 20;9(1):33. doi: 10.1186/1550-2783-9-33.
PubMed 22817979Forbes SC, Candow DG, Neto JHF, Kennedy MD, Forbes JL, Machado M, Bustillo E, Gomez-Lopez J, Zapata A, Antonio J. Creatine supplementation and endurance performance: surges and sprints to win the race. J Int Soc Sports Nutr. 2023 Dec;20(1):2204071. doi: 10.1080/15502783.2023.2204071.
PubMed 37096381Kurmazovic N, Nomikos T, Adamakis M, Forbes SC, Arnaoutis G, Djordjevic B, Todorovic V, Kritsiligkos P. Load and breath-hold: impact of 7-day creatine monohydrate loading on breath-hold exercise performance - a double-blind randomized controlled trial. J Int Soc Sports Nutr. 2026 Dec 31;23(sup1):2732743. doi: 10.1080/15502783.2026.2732743. Epub 2026 Oct 13.
PubMed 42868132
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Creatine Monohydrate Supplementation on Breath-Hold Exercise Performance on a Bicycle Ergometer
- ClinicalTrials.gov ID
- NCT07233707
- Acronym / sponsor ID
- BREATHE-C / 3301/21-07-2025
- Conditions
- Healthy
- Keywords
- breath-hold exercise performance, creatine monohydrate loading, supplementation, bicycle ergometer, ergogenic aid, anaerobic endurance performance, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Belgrade
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 26 Nov 2025 (estimated)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 18 Nov 2025 (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.
The present study aims to investigate the effects of creatine monohydrate supplementation on maximal breath-hold exercise performance on a bicycle ergometer in trained breath-hold divers. The testing protocol is specifically designed to replicate the physiological demands and exercise intensity of a maximal dynamic breath-hold dive.
Creatine supplementation may improve breath-hold exercise capacity by acting as a rapid, anaerobic energy source that is independent of oxygen availability that does not generate fatigue-inducing metabolic byproducts. Furthermore, its intracellular buffering properties may help delay the onset of metabolic acidosis, thereby possibly prolonging muscular work under hypoxic conditions.
Therefore, the main questions the study aims to answer are:
- Can creatine monohydrate loading supplementation protocol improve breath-hold exercise performance by increasing total work (TW) and time to exhaustion (TTE)?
- Can it will increase lactate threshold and delay the onset of the metabolic acidosis?
Researchers will compare creatine monohydrate supplementation to a placebo (maltodextrin) to determine whether creatine improves maximal breath-hold exercise performance on a bicycle ergometer in trained breath-hold divers.
Participants will:
- Attend scheduled laboratory visits on 4 occasions (one for performing graded exercise test (GXT), one for familiarization with the breath-hold exercise (BHE) protocol, one for pre-supplementation BHE testing, one for post-supplementation BHE testing)
- Take creatine monohydrate or a placebo for 7 days (5g four times per day)
- Report any discomforts during supplementation period, log the type and frequency of their trainings 7 days prior to pre and post-supplementation testing, report everything they ate and drunk on the day prior to the pre and post-supplementation testing
Detailed description
Creatine is well known for its role in enhancing adenosine triphosphate (ATP) regeneration and therefore aiding in short high-intensity activities, improving work capacity and power output of skeletal muscle, and delaying the onset of muscle fatigue. However, research on creatine supplementation in endurance sports has yielded inconsistent results. Some studies in this field showed improved endurance performance, while others failed to demonstrate it, or even showed decrements in it. This variability may stem from different supplementation protocols or the wide range of protocols used for measuring performance. Additionally, the increase in body mass resulting from creatine's osmotic properties may negatively impact performance in weight-bearing sports. Another factor may be muscle fiber composition, as individuals who respond best to creatine supplementation typically have a higher proportion of type II muscle fibers, whereas endurance athletes usually predominantly possess type I fibers.
Breath-hold diving is the practice of diving underwater on a single breath. Sport disciplines in breath-hold diving can be divided into three categories: static breath-hold, depth disciplines and dynamic disciplines. Static breath-hold focus on holding the breath for the longest possible time, depth disciplines focus on reaching the greatest possible depth underwater, while dynamic disciplines focus on covering the greatest possible distance underwater on a single breath. These disciplines test diver's oxygen (O2) management, metabolic byproducts tolerance, movement efficiency and energy conservation. Some of the limitations in breath-hold diving include tolerance to fatigue-inducing metabolic byproducts, the buildup of carbon dioxide (CO2) and O2 availability. As dive time and the muscular activity increase, O2 levels decrease, and reliance on anaerobic metabolic pathway intensifies, leading to the accumulation of metabolic byproducts such as lactate. Therefore, divers, among other things, train to optimize O2 utilization, to delay metabolic acidosis onset, and to enhance tolerance to elevated levels of metabolic byproducts.
Although breath-hold diving may not be considered a high-intensity sport in terms of heart rate and movement speed, it involves a unique performance pattern that includes limited availability of O2 and triggers a shift to anaerobic metabolism. This shift is sustained over extended periods, requiring significant effort and endurance to maintain performance. It is important to highlight that no form of exercise is purely anaerobic or aerobic, and that all energy systems contribute to ATP re-synthesis. However, their contribution depends on the nature of the activity. So, even though the phosphocreatine system may not dominate when it comes to endurance sports, it can still buffer energy demands and therefore prevent early onset of fatigue. Therefore, the energy produced by creatine phosphate (CP) is used for ATP yield as long as possible and it was shown that even though contribution of CP is reduced between 100 and 200 meters of running sprint, the CP stores are depleted only at the end of 400 meters.
As breath-hold diving requires efficient O2 utilization and as body relies predominantly on anaerobic metabolism that leads to metabolic acidosis, efficient ATP production, O2 utilization and CO2 production are crucial. Creatine supplementation may offer benefits by providing efficient energy production and delaying the onset of metabolic acidosis. In addition, creatine has an ability to buffer acidity by accepting and neutralizing excess hydrogen ions that accumulate in the muscles as a byproduct of anaerobic metabolism.
Lactate threshold (LT) is defined as the point of the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be cleared. A higher LT allows athletes to sustain higher speeds or higher power outputs before the onset of fatigue. Breath-hold divers could also benefit from a higher LT because of the delayed buildup of anaerobic metabolism byproducts. In various strength-endurance test protocols, creatine supplementation was suggested to increase LT, by improving ATP regeneration and increasing muscle buffering capacity, as well as to improve performance measured by total work (TW), time to exhaustion (TTE) and power output. Still, some studies failed to show improved endurance performance and increased LT.
In addition, ventilatory threshold (VT) is defined as the point during exercise at which ventilation increases disproportionately to O2 consumption due to the need to exhale accumulated CO2. VT is closely related to LT because when lactate starts accumulating, hydrogen ions accumulate too, non-metabolic CO2 production increases and so does the ventilatory rate. Nelson et al (2000) observed a significant lengthening of the run distance to the VT in long distance runners on a graded exercise test (GTX) after creatine supplementation. Authors concluded that this alteration resulted in the body being able to perform sub-maximal workload at a lower O2 cost and reduced work by cardiovascular system measured by heart rate.
Creatine supplementation may enhance breath-hold exercise performance by serving as an anaerobic alactic source of energy. Additionally, creatine has intracellular buffering properties that can help delay the onset of metabolic acidosis, thereby extending the duration of muscle work under hypoxic conditions.
The breath-hold exercise will be performed on a bicycle ergometer at an intensity matched to the maximal dynamic breath-hold dive, using heart rate as the indicator. The protocol is designed to replicate the key metabolic demands of dynamic breath-hold dive by requiring muscle work under hypoxic conditions.
Participants' heart rate after the maximal dynamic breath-hold dive will be accessed at their pool training. Individual end-dive heart rate (HR) will be used as indicator of exercise intensity for designing an individual breath-hold testing protocol for each participant. Participants will perform GXT in the laboratory in order to find the corresponding resistance on the bicycle ergometer that will match their end-dive HR. Therefore, the resistance on the bicycle ergometer that will be used for the final pre and post-supplementation testing will be defined by end-dive HR and data from GXT. Final testing will include cycling on the stationary ergometer where participants will be asked to cover the longest possible distance on one breath. Main measurements will include: distance covered on one breath, time of the breath-hold, pre and post-test lactate from the earlobe and rating of perceived exertion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate (CM) group | Experimental | Dietary Supplement: Creatine MonohydrateCM group will receive 20 grams of creatine monohydrate per day for 7 days |
| Placebo (PL) group | Placebo comparator | Dietary Supplement: Placebo ControlPL group will receive 20 grams of maltodextrin per day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy trained breath-hold divers (with at least one year of experience in dynamic breath-hold diving training and competition) who haven't been supplementing with creatine monohydrate for at least the past 6 weeks prior to the start of the study
Key exclusion criteria (3 listed)
- breath-hold divers with less than 1 year of experience in dynamic breath-hold training and competition
- breath-hold divers with any acute or chronic medical conditions
- breath-hold divers that supplement with creatine monohydrate or have been supplementing with creatine monohydrate in the past 6 weeks
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 |
|---|---|---|
| Creatine MonohydrateCreatine monohydrate 7-day loading phase | Dietary supplement | Creatine monohydrate (CM) group |
| Placebo Control20 grams of maltodextrin per day for 7 days | Dietary supplement | Placebo (PL) group |
Primary outcome
Total Work
Time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Performance will be evaluated based on two parameters, one of which is Total Work (TW). TW will represent distance covered on the bicycle ergometer on the maximum breath-hold exercise attempt. It will be measured on the bicycle ergometer Monark 839 E and expressed in meters.
Time to Exhaustion
Time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Performance will be evaluated based on two parameters, one of which is Time to Exhaustion (TTE). TTE will represent duration of the breath-hold during the maximum breath-hold exercise attempt. It will be measured on the bicycle ergometer Monark 839 E and expressed in seconds.
Lactate accumulation
Time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Lactate accumulation (the difference between lactate concentration in peripheral circulation immediately after exercise and that measured three minutes before exercise) will represent an objective indicator of fatigue. It will be measured from the earlobe using Lactate Scout 4 device, before and after maximum breath-hold exercise attempt, on both pre and post supplementation testing.
2 secondary outcomes
Rating of Perceived Exertion
Time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Change in Lean Body Mass
Time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 11072779Nelson AG, Day R, Glickman-Weiss EL, Hegsted M, Kokkonen J, Sampson B. Creatine supplementation alters the response to a graded cycle ergometer test. Eur J Appl Physiol. 2000 Sep;83(1):89-94. doi: 10.1007/s004210000244.
- Background: PubMed 9721002McNaughton LR, Dalton B, Tarr J. The effects of creatine supplementation on high-intensity exercise performance in elite performers. Eur J Appl Physiol Occup Physiol. 1998 Aug;78(3):236-40. doi: 10.1007/s004210050413.
- Background: PubMed 38747788Furtado ETF, Oliveira JPL, Pereira ISB, Veiga EP, Silva SFD, Abreu WC. Short term creatine loading improves strength endurance even without changing maximal strength, RPE, fatigue index, blood lactate, and mode state. An Acad Bras Cienc. 2024 May 10;96(2):e20230559. doi: 10.1590/0001-3765202420230559. eCollection 2024.
- Background: PubMed 32408412Lee S, Hong G, Park W, Lee J, Kim N, Park H, Park J. The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise. Phys Act Nutr. 2020 Mar 31;24(1):29-36. doi: 10.20463/pan.2020.0006.
- Background: PubMed 23164647Oliver JM, Joubert DP, Martin SE, Crouse SF. Oral creatine supplementation's decrease of blood lactate during exhaustive, incremental cycling. Int J Sport Nutr Exerc Metab. 2013 Jun;23(3):252-8. doi: 10.1123/ijsnem.23.3.252. Epub 2012 Nov 19.
- Background: PubMed 19885119Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414.
- Background: PubMed 1324108Hirvonen J, Nummela A, Rusko H, Rehunen S, Harkonen M. Fatigue and changes of ATP, creatine phosphate, and lactate during the 400-m sprint. Can J Sport Sci. 1992 Jun;17(2):141-4.
- Background: PubMed 29571233RodrIguez-Zamora L, Engan HK, Lodin-Sundstrom A, Schagatay F, Iglesias X, Rodriguez FA, Schagatay E. Blood lactate accumulation during competitive freediving and synchronized swimming. Undersea Hyperb Med. 2018 Jan-Feb;45(1):55-63.
- Background: PubMed 22817979Cooper R, Naclerio F, Allgrove J, Jimenez A. Creatine supplementation with specific view to exercise/sports performance: an update. J Int Soc Sports Nutr. 2012 Jul 20;9(1):33. doi: 10.1186/1550-2783-9-33.
- Background: PubMed 37096381Forbes SC, Candow DG, Neto JHF, Kennedy MD, Forbes JL, Machado M, Bustillo E, Gomez-Lopez J, Zapata A, Antonio J. Creatine supplementation and endurance performance: surges and sprints to win the race. J Int Soc Sports Nutr. 2023 Dec;20(1):2204071. doi: 10.1080/15502783.2023.2204071.
- Derived from this study: PubMed 42868132Kurmazovic N, Nomikos T, Adamakis M, Forbes SC, Arnaoutis G, Djordjevic B, Todorovic V, Kritsiligkos P. Load and breath-hold: impact of 7-day creatine monohydrate loading on breath-hold exercise performance - a double-blind randomized controlled trial. J Int Soc Sports Nutr. 2026 Dec 31;23(sup1):2732743. doi: 10.1080/15502783.2026.2732743. Epub 2026 Oct 13.
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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.
Natalija Kurmazovic, Master of Science principal investigator
Faculty of Pharmacy, University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Healthy, run by Harokopio University at 1 site in Greece.
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 3 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total Work (time frame: From enrollment to study (baseline/pre-supplementation testing) to end of the study (post-supplementation testing which takes place after 7 days of supplementation period)). The study lists 3 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 NCT07233707, which also lists 11 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 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.