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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Caffeine, Hypoxia
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.

Slovenia1 site
  • University of Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

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.

Conditions
Caffeine, Hypoxia
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 groups in NCT05764018
Study groupRoleWhat they receive
Normoxia-PlaceboPlacebo comparatorParticipants will be breathing room air, and ingest a flavoured drink containing only a trivial amount of maltodextrin.
Receives: Other: Placebo; Other: Normoxia
Normoxia-CaffeineExperimentalParticipants 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-PlaceboPlacebo comparatorParticipants 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-CaffeineExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  1. First posted10 Mar 2023
  2. Study start6 Mar 2023
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Resources

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)
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

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.

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