HypoxiaNCT06727656
Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?
A study testing Nitrate + Hypoxia in people with Hypoxia, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial summary
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Nitrate + Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2019to 22 Jul 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years
Who cannot join
- smoking or other chronic issues
- using medication or dietary supplements in the last 3 months, or during the duration of the study
- being exposed to altitude (≥2000 m) in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.
Read the detailed description
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.
- Conditions
- Hypoxia
- Being tested
- Nitrate + Hypoxia, Placebo + Hypoxia, Control
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate + HypoxiaCombination product
Also called Beetroot Juice + Atitude training
The combined effect of nitrate supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.
Placebo + HypoxiaDietary supplement
Also called Placebo Juice + Atitude training
The combined effect of placebo supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.
ControlOther
Also called Placebo Juice + Normoxia training
The combined effect of placebo supplementation and normoxia training on both performance and health at sea-level and altitude conditions.
| Study group | Role | What they receive |
|---|---|---|
| HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-). | Experimental | Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with NO3- supplement. Receives: Combination Product: Nitrate + Hypoxia |
| HPL: High intensity interval training (HIIT) + placebo supllementation. | Active comparator | Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with placebo supplement. Receives: Dietary Supplement: Placebo + Hypoxia |
| CON: High intensity interval training (HIIT) + placebo supllementation. | Placebo comparator | Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normoxic conditions (FiO2=~20.9%) with placebo supplement. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance adaptations
Time-to-task failure (time sustained)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Performance adaptations
Time trials (time performed)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Performance adaptations
VO2 kinetics (time constant and amplitude of fast and slow oxygen components)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Maximal oxygen uptake (VO2max: absolute and relative value)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Lactate threshold (absolute and percentage of VO2max)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Muscular oxygen saturation (SmO2)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Skeletal muscle adaptations
Oxidative enzyme activity (cytochrome oxidase subunit IV), citrate synthase, transcription factors (HIF-1alpha and PGC-1alpha) and GLUT4 - assessed through standard enzymatic fluorometric assay and western bllotting
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Skeletal muscle adaptations
Mitochondrial and capillary density, capillary-to-fibre ratio and fibre cross-section area - cryosections cut with a cryostat and further samples analysed by fluorescence microscopy
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Haematological adaptations
Blood pressure (Hmmg), mean arterial pressure (calculated as 1/3 * systolic pressure + 2/3 * diastolic pressure)
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Haematological adaptations
Plasma [NO2-] and [NO3-], erythropoietin (EPO), haemoglobin (Hb) and haematocrit (Hct) - all assays on plasma sample analysed by spectrophometry
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Oxidative stress and antioxidant markers adaptations
Nitrotyrosine, malondialdehyde, ferric-reducing antioxidant power and superoxide dismutase concentrations - all assays on plasma sample analysed by spectrophometry
Measured: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Secondary outcomes (5)
Sleep and cardiac autonomic activity adaptations
Sleep duration (minutes)
Measured: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Sleep efficiency (%)
Measured: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Wake up time (hours: minutes)
Measured: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Resting heart rate (bpm)
Measured: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Heart rate variability (lnRMSSD)
Measured: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Feb 2019
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Sousa, Advanced Bionics
- Investigators
- Ana Sousa, PhD, Principal investigator, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727656
- Sponsor's protocol ID
- Hypoxia
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study overview, participation criteria, study plan, contacts
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?
- ClinicalTrials.gov ID
- NCT06727656
- Acronym / sponsor ID
- Hypoxia
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 11 Dec 2024 (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.
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.
Detailed description
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-). | Experimental | Combination Product: Nitrate + HypoxiaPerformed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with NO3- supplement. |
| HPL: High intensity interval training (HIIT) + placebo supllementation. | Active comparator | Dietary Supplement: Placebo + HypoxiaPerformed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with placebo supplement. |
| CON: High intensity interval training (HIIT) + placebo supllementation. | Placebo comparator | Other: ControlPerformed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normoxic conditions (FiO2=~20.9%) with placebo supplement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years
Key exclusion criteria (3 listed)
- smoking or other chronic issues
- using medication or dietary supplements in the last 3 months, or during the duration of the study
- being exposed to altitude (≥2000 m) in the last 3 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 |
|---|---|---|
| Nitrate + HypoxiaAlso: Beetroot Juice + Atitude trainingThe combined effect of nitrate supplementation and hypoxia training on both performance and health at sea-level and altitude conditions. | Combination product | HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-). |
| Placebo + HypoxiaAlso: Placebo Juice + Atitude trainingThe combined effect of placebo supplementation and hypoxia training on both performance and health at sea-level and altitude conditions. | Dietary supplement | HPL: High intensity interval training (HIIT) + placebo supllementation. |
| ControlAlso: Placebo Juice + Normoxia trainingThe combined effect of placebo supplementation and normoxia training on both performance and health at sea-level and altitude conditions. | Other | CON: High intensity interval training (HIIT) + placebo supllementation. |
Primary outcome
Performance adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Time-to-task failure (time sustained)
Performance adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Time trials (time performed)
Performance adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
VO2 kinetics (time constant and amplitude of fast and slow oxygen components)
Cardiovascular and neuromuscular adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Maximal oxygen uptake (VO2max: absolute and relative value)
Cardiovascular and neuromuscular adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Lactate threshold (absolute and percentage of VO2max)
Cardiovascular and neuromuscular adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Muscular oxygen saturation (SmO2)
Skeletal muscle adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Oxidative enzyme activity (cytochrome oxidase subunit IV), citrate synthase, transcription factors (HIF-1alpha and PGC-1alpha) and GLUT4 - assessed through standard enzymatic fluorometric assay and western bllotting
Skeletal muscle adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Mitochondrial and capillary density, capillary-to-fibre ratio and fibre cross-section area - cryosections cut with a cryostat and further samples analysed by fluorescence microscopy
Haematological adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Blood pressure (Hmmg), mean arterial pressure (calculated as 1/3 * systolic pressure + 2/3 * diastolic pressure)
Haematological adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Plasma [NO2-] and [NO3-], erythropoietin (EPO), haemoglobin (Hb) and haematocrit (Hct) - all assays on plasma sample analysed by spectrophometry
Oxidative stress and antioxidant markers adaptations
Time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Nitrotyrosine, malondialdehyde, ferric-reducing antioxidant power and superoxide dismutase concentrations - all assays on plasma sample analysed by spectrophometry
5 secondary outcomes
Sleep and cardiac autonomic activity adaptations
Time frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
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 11 Dec 2024.
- Individual participant dataSharing planned: No. Study overview, participation criteria, study plan, contacts
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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.
Ana Sousa, PhD principal investigator
University of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate + Hypoxia in people with Hypoxia, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
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: finished, as of the sponsor's last update on 11 Dec 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 Portugal. 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?
Performance adaptations (time frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)). The study lists 11 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 11 Dec 2024.