Healthy AdultsNCT07216755
Effects of Breathing Training and Nitrate on Exercise at Simulated Altitude
A study testing Respiratory Muscle Training (RMT) and Dietary Supplement: Beetroot Juice Concentrate in people with Healthy Adults and Mechanical Ventilation Dependence, run by Embry-Riddle Aeronautical University at 1 site in United States.
Trial summary
This study investigates whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under simulated moderate altitude conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Mechanical Ventilation Dependence, Hypoxia
- What is being tested?
- Respiratory Muscle Training (RMT) and Dietary Supplement: Beetroot Juice Concentrate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Aug 2028
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between 18 and 40 years old.
- Recreationally active (performing ≥3 hours of structured physical activity per week).
- Non-smokers for at least the past 6 months.
- Free from any known cardiovascular, pulmonary, metabolic, or neuromuscular disease as determined by health screening questionnaire and medical history.
- Able to perform cycle ergometer exercise to volitional fatigue.
- Willing to abstain from high-nitrate foods and supplements (e.g., beets, spinach, arugula) for 48 hours prior to each testing session.
- Able and willing to provide written informed consent and comply with all study procedures.
Who cannot join
- Diagnosis of or history of heart disease, hypertension, diabetes, or chronic respiratory disorders (e.g., asthma, COPD).
- Current use of medications or supplements known to affect cardiovascular, metabolic, or respiratory function (e.g., beta-blockers, nitrates, stimulants).
- Smoking, vaping, or tobacco use within the past 6 months.
- Known allergy or intolerance to beetroot products or nitrates.
- Participation in another interventional research study within the past 30 days.
- Pregnant or breastfeeding women.
- Any orthopedic or musculoskeletal limitation preventing safe exercise testing.
- Failure to meet inclusion criteria or inability to complete familiarization and baseline testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Embry-Riddle Aeronautical University
Daytona Beach, Florida, 32114
Teri Gabriel, 1386-226-7179, teri.gabriel@erau.edu
Scott K Ferguson, Ph.D.
About this study
Official title: Impact of Respiratory Muscle Training and Nitrate Therapy on Exercise Tolerance in Simulated Altitude
This study investigates whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under simulated moderate altitude conditions. Exposure to reduced oxygen availability at altitude places additional strain on the cardiovascular and respiratory systems, which may limit endurance performance. By combining RMT-designed to strengthen the muscles involved in breathing-with nitrate therapy, which enhances nitric oxide availability and vascular function, this study aims to determine whether these interventions independently or synergistically improve oxygen delivery, reduce physiological strain, and enhance exercise performance. The findings will help identify non-pharmacological strategies to improve physical performance and tolerance to hypoxia in both clinical and operational environments.
Read the detailed description
This study is designed to test whether two non-drug interventions-respiratory muscle training (RMT) and dietary nitrate supplementation-can improve exercise performance and tolerance when oxygen levels are lower than normal, such as at moderate altitude.
When people exercise in low-oxygen environments, the body must work harder to deliver enough oxygen to the muscles. This can lead to faster fatigue and reduced endurance. Strengthening the breathing muscles and improving blood vessel function may help the body adapt better to these conditions. This study will explore how RMT and nitrate supplementation, either alone or together, affect breathing, blood flow, and exercise capacity.
Why This Study Is Being Done:
Researchers want to find out whether strengthening the breathing muscles through RMT, and increasing nitric oxide in the body through nitrate (found naturally in beetroot juice), can make it easier to exercise when oxygen is limited. Nitric oxide helps widen blood vessels and improve oxygen delivery to muscles. The goal is to learn if these approaches can help healthy adults perform better in low-oxygen conditions and whether combining them produces a greater benefit than using either one alone.
Who Will Participate:
Healthy, recreationally active adults will take part in this study. Participants will not have any known heart, lung, or metabolic disease. They will be randomly assigned to one of four groups:
Breathing training plus nitrate supplement
Breathing training plus placebo
Sham (fake) breathing training plus nitrate supplement
Sham (fake) breathing training plus placebo
What Participants Will Do:
Each participant will complete testing before and after a 4- to 6-week intervention period. During the intervention:
Participants in the RMT group will use a handheld breathing trainer several times per week to strengthen their breathing muscles.
Participants in the nitrate group will drink a small amount of concentrated beetroot juice daily.
Those in the sham groups will use a very low-resistance breathing device or a placebo drink that looks and tastes the same but contains no nitrate.
Before and after training, participants will perform exercise tests on a stationary bicycle both at normal oxygen levels and at simulated altitude inside a controlled environmental chamber. Testing will measure:
How long participants can exercise before becoming fatigued.
Oxygen use (VO₂), heart rate, breathing, and blood pressure during exercise.
Breathing muscle strength and endurance.
Oxygen levels in the blood and muscles.
Study Goals and Measurements:
Researchers will compare how exercise performance and physiological responses change with each treatment. The main goal is to see whether RMT and nitrate supplementation increase exercise tolerance at simulated altitude. Secondary goals include understanding how these interventions affect breathing patterns, oxygen use efficiency, and cardiovascular function during exercise.
Why This Study Matters:
This research will help scientists and health professionals understand how to improve physical performance and resilience when oxygen is limited. The findings could be useful for:
Pilots, military personnel, and athletes who train or work at altitude.
Patients with conditions that make breathing or exercise difficult, such as heart or lung disease.
Future spaceflight or aerospace medicine applications, where oxygen availability can vary.
Safety and Ethics:
All participants will give written informed consent before joining the study. The study has been reviewed and approved by the Institutional Review Board for the Protection of Human Subjects in Research at Embry-Riddle Aeronautical University. All research procedures will follow the ethical principles outlined in the Declaration of Helsinki.
Expected Impact:
The results will show whether combining breathing training with nitrate supplementation can serve as a simple, non-pharmacological strategy to improve tolerance to low-oxygen environments. This could lead to better performance strategies for athletes, aviators, and others who face hypoxic or high-altitude conditions, as well as inform clinical approaches for patients who struggle with exercise intolerance.
- Conditions
- Healthy Adults, Mechanical Ventilation Dependence, Hypoxia, Exercise Training, Exercise Intolerance, Dietary Supplement
- Being tested
- Respiratory Muscle Training (RMT), Sham Respiratory Muscle Training, Dietary Supplement: Beetroot Juice Concentrate, placebo beverage
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle Training (RMT)Device
Also called Inspiratory Muscle Training
Participants perform supervised respiratory muscle training (RMT) using a handheld resistive breathing device designed to strengthen the inspiratory and expiratory muscles. Training sessions are conducted 5 days per week for approximately 4-6 weeks. Each session includes a series of resisted breathing maneuvers with progressively increased load as tolerated. The device is calibrated to maintain a constant pressure threshold to ensure consistent training intensity.
Sham Respiratory Muscle TrainingDevice
Participants use an identical handheld breathing device with minimal resistance, providing no meaningful training stimulus. The training schedule and session duration match those of the active RMT group to maintain participant blinding.
Dietary Supplement: Beetroot Juice ConcentrateDietary supplement
Participants consume a standardized dose of concentrated beetroot juice daily for the duration of the training period (approximately 4-6 weeks). The supplement provides a fixed quantity of dietary nitrate known to enhance nitric oxide availability and support vascular and metabolic function during exercise.
placebo beverageDietary supplement
Participants consume a placebo beverage identical in color, taste, and appearance to the nitrate supplement but containing no active nitrate. The beverage is consumed daily following the same schedule as the active supplement.
| Study group | Role | What they receive |
|---|---|---|
| RMT + Nitrate Supplementation | Experimental | Participants complete a multi-week respiratory muscle training (RMT) program using a handheld breathing device that provides progressive inspiratory and expiratory resistance. Participants also consume a daily standardized dose of beetroot juice concentrate containing dietary nitrate. This combination is expected to enhance breathing muscle strength, vascular function, and exercise tolerance under simulated altitude. Receives: Device: Respiratory Muscle Training (RMT); Dietary Supplement: Dietary Supplement: Beetroot Juice Concentrate |
| Respiratory Muscle Training + Placebo | Placebo comparator | Participants perform the same RMT program as in Arm 1 but consume a placebo beverage that is visually and taste-matched to the nitrate drink but contains no active nitrate. This group allows assessment of the independent effects of respiratory muscle training. Receives: Device: Respiratory Muscle Training (RMT); Dietary Supplement: placebo beverage |
| Sham Respiratory Muscle Training + Nitrate Supplementation | Sham comparator | Participants perform sham RMT with a very low resistance load that does not provide a training stimulus, while consuming the active nitrate beverage daily. This group isolates the independent effect of nitrate supplementation on exercise tolerance under hypoxic conditions. Receives: Device: Sham Respiratory Muscle Training; Dietary Supplement: Dietary Supplement: Beetroot Juice Concentrate |
| Sham Respiratory Muscle Training + Placebo | Placebo comparator | Participants complete sham RMT with minimal breathing resistance and consume a placebo beverage identical in appearance and flavor to the nitrate supplement but containing no active ingredients. This serves as the control condition for comparison with all other intervention groups. Receives: Device: Sham Respiratory Muscle Training; Dietary Supplement: placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Tolerance at Simulated Altitude
Exercise tolerance will be measured as the time to exhaustion during a graded cycling exercise test performed under simulated moderate altitude conditions (~2,500-3,000 meters). Tests will be conducted before and after the 4-6 week intervention period. The measure reflects overall improvements in aerobic performance and fatigue resistance following respiratory muscle training, nitrate supplementation, or their combination.
Measured: Baseline to Post-Intervention (approximately 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Embry-Riddle Aeronautical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Kohman Ferguson, Embry-Riddle Aeronautical University
- Investigators
- Scott K Ferguson, Ph.D., Principal investigator, Embry-Riddle Aeronautical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216755
- Sponsor's protocol ID
- 25-077
- Other IDs
- 1R15HL173855-01A1
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Muscle Training and Nitrate Therapy on Exercise Tolerance in Simulated Altitude
- ClinicalTrials.gov ID
- NCT07216755
- Acronym / sponsor ID
- 25-077
- Conditions
- Healthy Adults, Mechanical Ventilation Dependence, Hypoxia, Exercise Training, Exercise Intolerance, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Embry-Riddle Aeronautical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Oct 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.
This study investigates whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under simulated moderate altitude conditions. Exposure to reduced oxygen availability at altitude places additional strain on the cardiovascular and respiratory systems, which may limit endurance performance. By combining RMT-designed to strengthen the muscles involved in breathing-with nitrate therapy, which enhances nitric oxide availability and vascular function, this study aims to determine whether these interventions independently or synergistically improve oxygen delivery, reduce physiological strain, and enhance exercise performance. The findings will help identify non-pharmacological strategies to improve physical performance and tolerance to hypoxia in both clinical and operational environments.
Detailed description
This study is designed to test whether two non-drug interventions-respiratory muscle training (RMT) and dietary nitrate supplementation-can improve exercise performance and tolerance when oxygen levels are lower than normal, such as at moderate altitude.
When people exercise in low-oxygen environments, the body must work harder to deliver enough oxygen to the muscles. This can lead to faster fatigue and reduced endurance. Strengthening the breathing muscles and improving blood vessel function may help the body adapt better to these conditions. This study will explore how RMT and nitrate supplementation, either alone or together, affect breathing, blood flow, and exercise capacity.
Why This Study Is Being Done:
Researchers want to find out whether strengthening the breathing muscles through RMT, and increasing nitric oxide in the body through nitrate (found naturally in beetroot juice), can make it easier to exercise when oxygen is limited. Nitric oxide helps widen blood vessels and improve oxygen delivery to muscles. The goal is to learn if these approaches can help healthy adults perform better in low-oxygen conditions and whether combining them produces a greater benefit than using either one alone.
Who Will Participate:
Healthy, recreationally active adults will take part in this study. Participants will not have any known heart, lung, or metabolic disease. They will be randomly assigned to one of four groups:
Breathing training plus nitrate supplement
Breathing training plus placebo
Sham (fake) breathing training plus nitrate supplement
Sham (fake) breathing training plus placebo
What Participants Will Do:
Each participant will complete testing before and after a 4- to 6-week intervention period. During the intervention:
Participants in the RMT group will use a handheld breathing trainer several times per week to strengthen their breathing muscles.
Participants in the nitrate group will drink a small amount of concentrated beetroot juice daily.
Those in the sham groups will use a very low-resistance breathing device or a placebo drink that looks and tastes the same but contains no nitrate.
Before and after training, participants will perform exercise tests on a stationary bicycle both at normal oxygen levels and at simulated altitude inside a controlled environmental chamber. Testing will measure:
How long participants can exercise before becoming fatigued.
Oxygen use (VO₂), heart rate, breathing, and blood pressure during exercise.
Breathing muscle strength and endurance.
Oxygen levels in the blood and muscles.
Study Goals and Measurements:
Researchers will compare how exercise performance and physiological responses change with each treatment. The main goal is to see whether RMT and nitrate supplementation increase exercise tolerance at simulated altitude. Secondary goals include understanding how these interventions affect breathing patterns, oxygen use efficiency, and cardiovascular function during exercise.
Why This Study Matters:
This research will help scientists and health professionals understand how to improve physical performance and resilience when oxygen is limited. The findings could be useful for:
Pilots, military personnel, and athletes who train or work at altitude.
Patients with conditions that make breathing or exercise difficult, such as heart or lung disease.
Future spaceflight or aerospace medicine applications, where oxygen availability can vary.
Safety and Ethics:
All participants will give written informed consent before joining the study. The study has been reviewed and approved by the Institutional Review Board for the Protection of Human Subjects in Research at Embry-Riddle Aeronautical University. All research procedures will follow the ethical principles outlined in the Declaration of Helsinki.
Expected Impact:
The results will show whether combining breathing training with nitrate supplementation can serve as a simple, non-pharmacological strategy to improve tolerance to low-oxygen environments. This could lead to better performance strategies for athletes, aviators, and others who face hypoxic or high-altitude conditions, as well as inform clinical approaches for patients who struggle with exercise intolerance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RMT + Nitrate Supplementation | Experimental | Device: Respiratory Muscle Training (RMT), Dietary Supplement: Dietary Supplement: Beetroot Juice ConcentrateParticipants complete a multi-week respiratory muscle training (RMT) program using a handheld breathing device that provides progressive inspiratory and expiratory resistance. Participants also consume a daily standardized dose of beetroot juice concentrate containing dietary nitrate. This combination is expected to enhance breathing muscle strength, vascular function, and exercise tolerance under simulated altitude. |
| Respiratory Muscle Training + Placebo | Placebo comparator | Device: Respiratory Muscle Training (RMT), Dietary Supplement: placebo beverageParticipants perform the same RMT program as in Arm 1 but consume a placebo beverage that is visually and taste-matched to the nitrate drink but contains no active nitrate. This group allows assessment of the independent effects of respiratory muscle training. |
| Sham Respiratory Muscle Training + Nitrate Supplementation | Sham comparator | Device: Sham Respiratory Muscle Training, Dietary Supplement: Dietary Supplement: Beetroot Juice ConcentrateParticipants perform sham RMT with a very low resistance load that does not provide a training stimulus, while consuming the active nitrate beverage daily. This group isolates the independent effect of nitrate supplementation on exercise tolerance under hypoxic conditions. |
| Sham Respiratory Muscle Training + Placebo | Placebo comparator | Device: Sham Respiratory Muscle Training, Dietary Supplement: placebo beverageParticipants complete sham RMT with minimal breathing resistance and consume a placebo beverage identical in appearance and flavor to the nitrate supplement but containing no active ingredients. This serves as the control condition for comparison with all other intervention groups. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults between 18 and 40 years old.
- Recreationally active (performing ≥3 hours of structured physical activity per week).
- Non-smokers for at least the past 6 months.
- Free from any known cardiovascular, pulmonary, metabolic, or neuromuscular disease as determined by health screening questionnaire and medical history.
- Able to perform cycle ergometer exercise to volitional fatigue.
Key exclusion criteria (8 listed)
- Diagnosis of or history of heart disease, hypertension, diabetes, or chronic respiratory disorders (e.g., asthma, COPD).
- Current use of medications or supplements known to affect cardiovascular, metabolic, or respiratory function (e.g., beta-blockers, nitrates, stimulants).
- Smoking, vaping, or tobacco use within the past 6 months.
- Known allergy or intolerance to beetroot products or nitrates.
- Participation in another interventional research study within the past 30 days.
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 |
|---|---|---|
| Respiratory Muscle Training (RMT)Also: Inspiratory Muscle TrainingParticipants perform supervised respiratory muscle training (RMT) using a handheld resistive breathing device designed to strengthen the inspiratory and expiratory muscles. Training sessions are conducted 5 days per week for approximately 4-6 weeks. Each session includes a series of resisted breathing maneuvers with progressively increased load as tolerated. The device is calibrated to maintain a constant pressure threshold to ensure consistent training intensity. | Device | RMT + Nitrate Supplementation, Respiratory Muscle Training + Placebo |
| Sham Respiratory Muscle TrainingParticipants use an identical handheld breathing device with minimal resistance, providing no meaningful training stimulus. The training schedule and session duration match those of the active RMT group to maintain participant blinding. | Device | Sham Respiratory Muscle Training + Nitrate Supplementation, Sham Respiratory Muscle Training + Placebo |
| Dietary Supplement: Beetroot Juice ConcentrateParticipants consume a standardized dose of concentrated beetroot juice daily for the duration of the training period (approximately 4-6 weeks). The supplement provides a fixed quantity of dietary nitrate known to enhance nitric oxide availability and support vascular and metabolic function during exercise. | Dietary supplement | RMT + Nitrate Supplementation, Sham Respiratory Muscle Training + Nitrate Supplementation |
| placebo beverageParticipants consume a placebo beverage identical in color, taste, and appearance to the nitrate supplement but containing no active nitrate. The beverage is consumed daily following the same schedule as the active supplement. | Dietary supplement | Respiratory Muscle Training + Placebo, Sham Respiratory Muscle Training + Placebo |
Primary outcome
Change in Exercise Tolerance at Simulated Altitude
Time frame: Baseline to Post-Intervention (approximately 4-6 weeks)
Exercise tolerance will be measured as the time to exhaustion during a graded cycling exercise test performed under simulated moderate altitude conditions (~2,500-3,000 meters). Tests will be conducted before and after the 4-6 week intervention period. The measure reflects overall improvements in aerobic performance and fatigue resistance following respiratory muscle training, nitrate supplementation, or their combination.
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 15 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Scott K Ferguson, Ph.D. principal investigator
Embry-Riddle Aeronautical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Training (RMT) and Dietary Supplement: Beetroot Juice Concentrate in people with Healthy Adults and Mechanical Ventilation Dependence, run by Embry-Riddle Aeronautical University at 1 site in United States.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 United States. 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?
Contact Scott Ferguson K Ferguson, Ph.D. (386-226-7381, ferguss8@erau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Tolerance at Simulated Altitude (time frame: Baseline to Post-Intervention (approximately 4-6 weeks)). 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 15 Oct 2025.