CaffeineHypoCaffNCT05764018
Caffeine and Hypoxia During Exercise in Males and Females
A study testing Caffeine, Hypoxia and Normoxia in people with Caffeine and Hypoxia, run by Jozef Stefan Institute at 1 site in Slovenia.
Trial summary
Several high-altitude destinations recommend their visitors to avoid caffeine, theoretically due to the associated diuresis which could contribute to acute mountain sickness. There is however no direct evidence for this association. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Caffeine, Hypoxia and Normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Mar 2023to 19 Mar 2024
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regularly physically active (at least 30 mins of structured exercise 5 times per week).
- Sea-level natives.
Who cannot join
- presence of any medical risk factors to exercise and/or exposure to altitude
- presence of any medical condition that would make the protocol unreasonably hazardous for the participant
- smokers
- exposure to altitude above 2000 m in the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex Differences in the Acute Effects of Caffeine Supplementation on Exercise in Normobaric Hypoxia
Several high-altitude destinations recommend their visitors to avoid caffeine, theoretically due to the associated diuresis which could contribute to acute mountain sickness. There is however no direct evidence for this association. In fact, caffeine ingestion is known to improve exercise performance at sea level, and may therefore help mountaineers during expeditions.
Sport science research is largely conducted in male participants, and the findings from these studies are assumed to apply to the female population. Given the known sex differences in body composition, hormones, and other physiological factors, this may not be appropriate. It is therefore important to conduct research in women, to allow for female-specific recommendations.
Read the detailed description
As a result of transportation modernisation and tourism development, an increasing number of individuals are visiting high-altitude destinations for work and leisure purposes. The resulting exposure to (hypobaric) hypoxia is known to reduce exercise capacity due to a reduction in maximal oxygen uptake induced by lower oxygen pressure throughout the oxygen cascade. Several high-altitude destinations recommend their visitors to reduce or completely avoid caffeine intake during their stay. This recommendation is often based on the diuretic effects of caffeine, as the increased fluid loss through urine could accentuate dehydration, potentially contributing to feelings of acute mountain sickness. However, there is currently no scientific evidence to substantiate this recommendation. In fact, caffeine is known to be a particularly effective stimulant to improve exercise performance at sea level. Caffeine could therefore help mountaineers who engage in relatively intense physical activity during expeditions at altitude. The mechanisms underlying the ergogenic effects of caffeine are believed to originate centrally and peripherally. Of particular interest is the potential for caffeine to increase ventilation at submaximal and maximal exercise intensities. In a high-altitude environment, this could help to offset exercise- and hypoxia-induced hypoxemia, thereby enhancing exercise capacity.
Some studies have indeed provided evidence for the notion that caffeine could enhance exercise capabilities in hypoxia. Caffeine doses of 4.0 - 6.0 mg/kg body mass have been assessed, in (simulated and terrestrial) altitude environments equating to 2000 - 4300 m. In each case, it appeared that exercise performance and/or capacity at altitude could indeed be enhanced by caffeine ingestion. However, further mechanistic work is required, particularly in the assessment of the physiological effects of caffeine beyond typical exercise performance (time trial) and exercise capacity (peak power output, maximal oxygen uptake) outcomes. An enhanced holistic understanding of respiratory, cardiovascular, muscular and metabolic responses to exercise, caffeine and hypoxia is necessary to understand if caffeine ingestion at altitude is advisable.
Sport science research is largely conducted in male participants, and the findings from these studies are assumed to also apply to the female population. However, given the known sex differences in body composition, hormones, and other physiological factors, these assumptions may not be appropriate. It is therefore important to conduct research in women, to allow female-specific recommendations to be applied to athletes and to the general population.
As these are important considerations, the aim of this project is to investigate the effects of caffeine supplementation on exercise in hypoxia, and to determine whether these effects are influenced by sex differences.
24 healthy adult participants (12 male, 12 female) will be recruited to take part in the project. A preliminary testing session will be used to determine the maximal oxygen uptake of the participants in normoxia, and to familiarise them with the main trial protocol. A second preliminary laboratory visit will be used to measure the resting metabolic rate of the participants.
The main phase of the experiment will be a four-trial randomised crossover study; normoxia (ambient) vs. hypoxia (fraction of inspired oxygen = 0.13) and placebo (20 g maltodextrin) vs. caffeine (20 g maltodextrin + 6 mg/kg body mass caffeine). Participants will avoid caffeine, alcohol and intense exercise for 24 h prior to each laboratory visit. They will also replicate their diet for 24 h before each main trial. Each main trial will involve a 20-minute moderate-intensity cycling period, immediately followed by an incremental exercise test to exhaustion. Participants will be blinded to the environmental condition and the contents of the test drink. Outcome measures will include gas exchange variables, blood glucose/lactate concentration, muscle and brain oxygenation, blood oxygen saturation, heart rate and rating of perceived exertion. These measurements will provide a holistic overview of the broad physiological response to exercise, hypoxia and caffeine.
- Being tested
- Caffeine, Hypoxia, Placebo, Normoxia
- Keywords
- Caffeine, Hypoxia, Female physiology, Exercise
- Medical subject headings
- Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
Negligible amount of maltodextrin in flavoured drink solution containing 6 mg/kg body mass caffeine provided 45 minutes before exercise
HypoxiaOther
Also called Simulated altitude
Participants will be breathing from a hypoxic gas mixture (13% O2) for the duration of the exercise bout. This will simulate an altitude of approximately 3500 m.
PlaceboOther
Also called No caffeine
Negligible amount of maltodextrin in flavoured drink solution provided 45 minutes before exercise.
NormoxiaOther
Also called Sea level
Participants will be breathing from ambient air (~21% O2) for the duration of the exercise bout. This will provide no hypoxic stimulus as the laboratory is located relatively near sea level (295 m)
| Study group | Role | What they receive |
|---|---|---|
| Normoxia-Placebo | Placebo comparator | Participants will be breathing room air, and ingest a flavoured drink containing only a trivial amount of maltodextrin. Receives: Other: Placebo; Other: Normoxia |
| Normoxia-Caffeine | Experimental | Participants will be breathing room air, and ingest a flavoured drink containing a trivial amount of maltodextrin and 6 mg/kg body mass caffeine. Receives: Dietary Supplement: Caffeine; Other: Normoxia |
| Hypoxia-Placebo | Placebo comparator | Participants will be breathing a 13% oxygen gas mixture, and ingest a flavoured drink containing only a trivial amount of maltodextrin. Receives: Other: Hypoxia; Other: Placebo |
| Hypoxia-Caffeine | Experimental | Participants will be breathing a 13% oxygen gas mixture, and ingest a flavoured drink containing a trivial amount of maltodextrin and 6 mg/kg body mass caffeine. Receives: Dietary Supplement: Caffeine; Other: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Peak oxygen consumption (VO2peak, ml/kg/min) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Measured: Immediately prior to volitional exhaustion during the incremental exercise test
Maximal aerobic power
Maximal aerobic power (MAP, W) will be quantified based on the time at which participants reach volitional exhaustion during the incremental exercise tests. This value will then be compared between groups and conditions.
Measured: At the instant of volitional exhaustion during the incremental exercise test
Peak minute ventilation
Peak minute ventilation (VEpeak, L/min) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Measured: Immediately prior to volitional exhaustion during the incremental exercise test
Peak heart rate
Peak heart rate (HRpeak, bpm) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Measured: Immediately prior to volitional exhaustion during the incremental exercise test
Muscle oxygenation nadir
The nadir in muscle oxygenation (TSIMmin, %) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Measured: Immediately prior to volitional exhaustion during the incremental exercise test
Peak blood lactate concentration
Blood lactate concentration will be measured immediately after the incremental exercise test to exhaustion ([BLapeak], mmol/L).
Measured: Immediately after volitional exhaustion during the incremental exercise test
Secondary outcomes (9)
Submaximal oxygen uptake
Oxygen consumption (VO2, L/min) will be continuously monitored during the exercise bouts under each condition. Absolute oxygen uptake during the submaximal exercise phases will be compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal minute ventilation
Minute ventilation (VE, L/min) will be continuously monitored during the exercise bouts under each condition, and values during the submaximal exercise phases will be compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal substrate oxidation
Substrate oxidation, as respiratory exchange ratio (RER, arbitrary units) will be continuously monitored during the exercise bouts under each condition. The relative contributions of fat and carbohydrate will be estimated using this variable and compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal muscle oxygenation
Muscle oxygenation, as tissue saturation index (TSIM, %), will be continuously monitored during the exercise bouts under each condition using near-infrared spectroscopy. Absolute muscle oxygenation during the submaximal exercise phases, will be compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal brain oxygenation
Brain oxygenation, as tissue saturation index (TSIB, %), will be continuously monitored during the exercise bouts under each condition using near-infrared spectroscopy. Absolute brain oxygenation during the submaximal exercise phases, will be compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal heart rate
Heart rate (HR, bpm), will be continuously monitored during the exercise bouts under each condition. Absolute heart rate during the submaximal exercise phases, will be compared between groups and conditions.
Measured: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Blood glucose concentration
Blood glucose concentration ([BG] mmol/L) will be measured at baseline and at the end of the submaximal exercise phase, to provide an indication of relative carbohydrate flux within each group and condition.
Measured: At rest prior to exercise, and at the end of the submaximal exercise period at 20 minutes.
Blood lactate concentration
Blood lactate concentration ([BLa] mmol/L) will be measured at baseline and at the end of the submaximal exercise phase, to provide an indication of anaerobic metabolism within each group and condition.
Measured: At rest prior to exercise, and at the end of the submaximal exercise period at 20 minutes.
Rating of perceived exertion
Ratings of perceived exertion will be measured throughout the submaximal exercise phases to establish the perception of workload, using a scale from 6 to 20 with higher values indicating a higher perception of exercise intensity. This will be compared between groups and conditions.
Measured: Every 5 minutes throughout the 20 minute submaximal exercise period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start6 Mar 2023
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies 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
- Crossover
- Model description
- Participants will perform four trials, to cover both levels of two factors; normoxia vs. hypoxia, and placebo vs. caffeine
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jozef Stefan Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadej Debevec, Jozef Stefan Institute
- Investigators
- Tadej Debevec, PhD, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764018
- Sponsor's protocol ID
- HypoCaff
- Acronym
- HypoCaff
- Status last verified
- Aug 2024
- First submitted
- 17 Feb 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in the Acute Effects of Caffeine Supplementation on Exercise in Normobaric Hypoxia
- ClinicalTrials.gov ID
- NCT05764018
- Acronym / sponsor ID
- HypoCaff / HypoCaff
- Keywords
- Caffeine, Hypoxia, Female physiology, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jozef Stefan InstituteUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 10 Mar 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.
Several high-altitude destinations recommend their visitors to avoid caffeine, theoretically due to the associated diuresis which could contribute to acute mountain sickness. There is however no direct evidence for this association. In fact, caffeine ingestion is known to improve exercise performance at sea level, and may therefore help mountaineers during expeditions.
Sport science research is largely conducted in male participants, and the findings from these studies are assumed to apply to the female population. Given the known sex differences in body composition, hormones, and other physiological factors, this may not be appropriate. It is therefore important to conduct research in women, to allow for female-specific recommendations.
Detailed description
As a result of transportation modernisation and tourism development, an increasing number of individuals are visiting high-altitude destinations for work and leisure purposes. The resulting exposure to (hypobaric) hypoxia is known to reduce exercise capacity due to a reduction in maximal oxygen uptake induced by lower oxygen pressure throughout the oxygen cascade. Several high-altitude destinations recommend their visitors to reduce or completely avoid caffeine intake during their stay. This recommendation is often based on the diuretic effects of caffeine, as the increased fluid loss through urine could accentuate dehydration, potentially contributing to feelings of acute mountain sickness. However, there is currently no scientific evidence to substantiate this recommendation. In fact, caffeine is known to be a particularly effective stimulant to improve exercise performance at sea level. Caffeine could therefore help mountaineers who engage in relatively intense physical activity during expeditions at altitude. The mechanisms underlying the ergogenic effects of caffeine are believed to originate centrally and peripherally. Of particular interest is the potential for caffeine to increase ventilation at submaximal and maximal exercise intensities. In a high-altitude environment, this could help to offset exercise- and hypoxia-induced hypoxemia, thereby enhancing exercise capacity.
Some studies have indeed provided evidence for the notion that caffeine could enhance exercise capabilities in hypoxia. Caffeine doses of 4.0 - 6.0 mg/kg body mass have been assessed, in (simulated and terrestrial) altitude environments equating to 2000 - 4300 m. In each case, it appeared that exercise performance and/or capacity at altitude could indeed be enhanced by caffeine ingestion. However, further mechanistic work is required, particularly in the assessment of the physiological effects of caffeine beyond typical exercise performance (time trial) and exercise capacity (peak power output, maximal oxygen uptake) outcomes. An enhanced holistic understanding of respiratory, cardiovascular, muscular and metabolic responses to exercise, caffeine and hypoxia is necessary to understand if caffeine ingestion at altitude is advisable.
Sport science research is largely conducted in male participants, and the findings from these studies are assumed to also apply to the female population. However, given the known sex differences in body composition, hormones, and other physiological factors, these assumptions may not be appropriate. It is therefore important to conduct research in women, to allow female-specific recommendations to be applied to athletes and to the general population.
As these are important considerations, the aim of this project is to investigate the effects of caffeine supplementation on exercise in hypoxia, and to determine whether these effects are influenced by sex differences.
24 healthy adult participants (12 male, 12 female) will be recruited to take part in the project. A preliminary testing session will be used to determine the maximal oxygen uptake of the participants in normoxia, and to familiarise them with the main trial protocol. A second preliminary laboratory visit will be used to measure the resting metabolic rate of the participants.
The main phase of the experiment will be a four-trial randomised crossover study; normoxia (ambient) vs. hypoxia (fraction of inspired oxygen = 0.13) and placebo (20 g maltodextrin) vs. caffeine (20 g maltodextrin + 6 mg/kg body mass caffeine). Participants will avoid caffeine, alcohol and intense exercise for 24 h prior to each laboratory visit. They will also replicate their diet for 24 h before each main trial. Each main trial will involve a 20-minute moderate-intensity cycling period, immediately followed by an incremental exercise test to exhaustion. Participants will be blinded to the environmental condition and the contents of the test drink. Outcome measures will include gas exchange variables, blood glucose/lactate concentration, muscle and brain oxygenation, blood oxygen saturation, heart rate and rating of perceived exertion. These measurements will provide a holistic overview of the broad physiological response to exercise, hypoxia and caffeine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will perform four trials, to cover both levels of two factors; normoxia vs. hypoxia, and placebo vs. caffeine
| Arm | Type | Receives |
|---|---|---|
| Normoxia-Placebo | Placebo comparator | Other: Placebo, Other: NormoxiaParticipants will be breathing room air, and ingest a flavoured drink containing only a trivial amount of maltodextrin. |
| Normoxia-Caffeine | Experimental | Dietary Supplement: Caffeine, Other: NormoxiaParticipants will be breathing room air, and ingest a flavoured drink containing a trivial amount of maltodextrin and 6 mg/kg body mass caffeine. |
| Hypoxia-Placebo | Placebo comparator | Other: Hypoxia, Other: PlaceboParticipants will be breathing a 13% oxygen gas mixture, and ingest a flavoured drink containing only a trivial amount of maltodextrin. |
| Hypoxia-Caffeine | Experimental | Dietary Supplement: Caffeine, Other: HypoxiaParticipants will be breathing a 13% oxygen gas mixture, and ingest a flavoured drink containing a trivial amount of maltodextrin and 6 mg/kg body mass caffeine. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Regularly physically active (at least 30 mins of structured exercise 5 times per week).
- Sea-level natives.
Key exclusion criteria (4 listed)
- presence of any medical risk factors to exercise and/or exposure to altitude
- presence of any medical condition that would make the protocol unreasonably hazardous for the participant
- smokers
- exposure to altitude above 2000 m in the last 2 months
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 |
|---|---|---|
| CaffeineNegligible amount of maltodextrin in flavoured drink solution containing 6 mg/kg body mass caffeine provided 45 minutes before exercise | Dietary supplement | Hypoxia-Caffeine, Normoxia-Caffeine |
| HypoxiaAlso: Simulated altitudeParticipants will be breathing from a hypoxic gas mixture (13% O2) for the duration of the exercise bout. This will simulate an altitude of approximately 3500 m. | Other | Hypoxia-Caffeine, Hypoxia-Placebo |
| PlaceboAlso: No caffeineNegligible amount of maltodextrin in flavoured drink solution provided 45 minutes before exercise. | Other | Hypoxia-Placebo, Normoxia-Placebo |
| NormoxiaAlso: Sea levelParticipants will be breathing from ambient air (~21% O2) for the duration of the exercise bout. This will provide no hypoxic stimulus as the laboratory is located relatively near sea level (295 m) | Other | Normoxia-Caffeine, Normoxia-Placebo |
Primary outcome
Peak oxygen uptake
Time frame: Immediately prior to volitional exhaustion during the incremental exercise test
Peak oxygen consumption (VO2peak, ml/kg/min) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Maximal aerobic power
Time frame: At the instant of volitional exhaustion during the incremental exercise test
Maximal aerobic power (MAP, W) will be quantified based on the time at which participants reach volitional exhaustion during the incremental exercise tests. This value will then be compared between groups and conditions.
Peak minute ventilation
Time frame: Immediately prior to volitional exhaustion during the incremental exercise test
Peak minute ventilation (VEpeak, L/min) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Peak heart rate
Time frame: Immediately prior to volitional exhaustion during the incremental exercise test
Peak heart rate (HRpeak, bpm) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Muscle oxygenation nadir
Time frame: Immediately prior to volitional exhaustion during the incremental exercise test
The nadir in muscle oxygenation (TSIMmin, %) will be quantified from the end of each maximal exercise test and compared between groups and conditions.
Peak blood lactate concentration
Time frame: Immediately after volitional exhaustion during the incremental exercise test
Blood lactate concentration will be measured immediately after the incremental exercise test to exhaustion ([BLapeak], mmol/L).
9 secondary outcomes
Submaximal oxygen uptake
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal minute ventilation
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal substrate oxidation
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal muscle oxygenation
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal brain oxygenation
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Submaximal heart rate
Time frame: From the onset of exercise to the end of the submaximal exercise period at 20 minutes.
Blood glucose concentration
Time frame: At rest prior to exercise, and at the end of the submaximal exercise period at 20 minutes.
Blood lactate concentration
Time frame: At rest prior to exercise, and at the end of the submaximal exercise period at 20 minutes.
Rating of perceived exertion
Time frame: Every 5 minutes throughout the 20 minute submaximal exercise period.
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 12 Aug 2024.
- 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.
Tadej Debevec, PhD principal investigator
University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine, Hypoxia and Normoxia in people with Caffeine and Hypoxia, run by Jozef Stefan Institute at 1 site in Slovenia.
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 2 inclusion and 4 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 12 Aug 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 Slovenia. 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?
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?
Peak oxygen uptake (time frame: Immediately prior to volitional exhaustion during the incremental exercise test). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2024.