Health Adult SubjectsNitrate TTENCT07735455
Dose-response Effects of Dietary Nitrate on Running Time-to-exhaustion and Neuromuscular Fatigue: a Randomized Crossover Exploratory Pilot Study
A study testing Dietary Nitrate in people with Health Adult Subjects, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
Background: Dietary nitrate is a natural compound found in vegetables such as beetroot and leafy greens. Previous research suggests that consuming nitrate before exercise may improve endurance and physical performance. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- Dietary Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 30 Sep 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male adults aged 18 to 40 years.
- Recreationally trained, performing endurance or combined endurance/resistance exercise at least 3 times per week for the previous 6 months.
- Maximal oxygen uptake (VO₂max) consistent with recreational training status.
- Able to perform maximal treadmill running exercise.
- Willing and able to comply with all study procedures.
- Provided written informed consent before participation
Who cannot join
- Current smoking or use of nicotine products.
- History of cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal disorders that could affect exercise performance or participant safety.
- Current use of medications or dietary supplements known to influence nitric oxide metabolism or exercise performance (e.g., nitrate supplements, phosphodiesterase-5 inhibitors, antibacterial mouthwash).
- Allergy or intolerance to beetroot or any component of the study supplements.
- Following a vegetarian or vegan diet, or habitually consuming a high-nitrate diet.
- Consumption of alcohol, caffeine, or strenuous physical exercise within the period restricted by the study protocol before each experimental visit.
- Failure to comply with pre-test dietary or behavioral instructions. Participation in another clinical trial within the previous 30 days.
- Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of the results.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Dietary nitrate is a natural compound found in vegetables such as beetroot and leafy greens. Previous research suggests that consuming nitrate before exercise may improve endurance and physical performance. However, it is still unclear whether higher doses provide greater benefits, particularly in recreationally trained individuals.
Purpose: This study aimed to investigate whether different doses of dietary nitrate taken before exercise influence endurance performance and muscle fatigue during a running test in recreationally trained men.
Methods: This randomized, double-blind, placebo-controlled crossover pilot study compared the effects of a placebo and three different doses of dietary nitrate consumed before exercise. On separate occasions, participants completed the same treadmill running test to exhaustion after ingesting the assigned supplement. Measures of muscle performance, blood lactate concentration, and perceived exertion were collected before and after exercise to evaluate the effects of dietary nitrate supplementation.
Read the detailed description
Dietary nitrate (NO₃-), naturally present in vegetables such as beetroot and leafy greens, can be converted into nitric oxide (NO) through the nitrate-nitrite-NO pathway. Nitric oxide plays an important role in regulating blood flow, muscle contractility, mitochondrial efficiency, and oxygen utilization during exercise. For these reasons, dietary nitrate supplementation has attracted considerable interest as a nutritional strategy to enhance exercise performance.
Previous studies have reported improvements in endurance performance following acute dietary nitrate supplementation, particularly with doses between 5 and 9 mmol. However, the optimal dose for maximizing potential ergogenic effects remains uncertain, especially in recreationally trained individuals. Furthermore, limited evidence is available regarding the dose-response relationship between nitrate supplementation and exercise-induced neuromuscular fatigue.
This pilot study was designed to evaluate the acute effects of three different doses of dietary nitrate compared with placebo using a randomized, double-blind, placebo-controlled crossover design. Each participant completed four experimental trials, receiving placebo or one of three nitrate doses in a randomized order before performing an identical treadmill running test to exhaustion at the speed corresponding to the second ventilatory threshold (VT2). Neuromuscular performance, blood lactate concentration, and perceived exertion were assessed before and after exercise using standardized procedures.
The findings of this study are expected to contribute to a better understanding of the dose-response relationship of acute dietary nitrate supplementation and to support the design of larger clinical trials investigating its effects on endurance performance and neuromuscular function.
- Conditions
- Health Adult Subjects
- Being tested
- Dietary Nitrate, Placebo
- Keywords
- beetroot juice, exercise tolerance, muscle power, recreational athletes, acute supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary NitrateDietary supplement
Participants received a single acute dose of dietary nitrate before exercise. Three doses were evaluated (4.8 mmol, 8.1 mmol, and 11.3 mmol), administered approximately 2.5 hours before the treadmill running test.
PlaceboOther
Participants received a nitrate-depleted placebo beverage approximately 2.5 hours before the treadmill running test.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive placebo before exercise. Receives: Other: Placebo |
| 4.8 mmol Dietary Nitrate | Experimental | Participants receive 4.8 mmol dietary nitrate before exercise. Receives: Dietary Supplement: Dietary Nitrate |
| 8.1 mmol Dietary Nitrate | Experimental | Participants receive 8.1 mmol dietary nitrate before exercise. Receives: Dietary Supplement: Dietary Nitrate |
| 11.3 mmol Dietary Nitrate | Experimental | Participants receive 11.3 mmol dietary nitrate before exercise. Receives: Dietary Supplement: Dietary Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Exhaustion (TTE)
Time to exhaustion during a constant-speed treadmill running test performed at the speed corresponding to the second ventilatory threshold (VT2). Time was recorded in seconds from the start of the test until volitional exhaustion.
Measured: Baseline (single exercise session, approximately 2.5 hours after supplementation)
Secondary outcomes (5)
Countermovement Jump (CMJ) Height
Vertical jump height assessed using a countermovement jump test before and immediately after the treadmill running test to evaluate lower-limb neuromuscular performance.
Measured: Immediately before supplementation exercise and immediately after exercise
Drop Jump (DJ) Height
Vertical jump height measured during a drop jump test before and immediately after the treadmill running test to assess reactive neuromuscular performance.
Measured: Immediately before exercise and immediately after exercise
Isometric Deadlift Peak Force
Peak force generated during an isometric deadlift test performed before and immediately after the treadmill running test.
Measured: Immediately before supplementation and immediately after exercise
Blood Lactate Concentration
Blood lactate concentration measured from capillary blood samples before and immediately after the treadmill running test.
Measured: Immediately before exercise and immediately after exercise
Rating of Perceived Exertion (RPE)
Perceived exertion assessed using the Borg Rating of Perceived Exertion Scale immediately after completion of the treadmill running test.
Measured: Immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Adult SubjectsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Gilsanz, Universidad Autonoma de Madrid
- Investigators
- Helios Pareja Galeano, Study director, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735455
- Sponsor's protocol ID
- CEI-130- 2688
- Acronym
- Nitrate TTE
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.
PubMed 23640589
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effects of Dietary Nitrate on Running Time-to-exhaustion and Neuromuscular Fatigue: a Randomized Crossover Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT07735455
- Acronym / sponsor ID
- Nitrate TTE / CEI-130- 2688
- Conditions
- Health Adult Subjects
- Keywords
- beetroot juice, exercise tolerance, muscle power, recreational athletes, acute supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 30 Jul 2026 (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.
Background: Dietary nitrate is a natural compound found in vegetables such as beetroot and leafy greens. Previous research suggests that consuming nitrate before exercise may improve endurance and physical performance. However, it is still unclear whether higher doses provide greater benefits, particularly in recreationally trained individuals.
Purpose: This study aimed to investigate whether different doses of dietary nitrate taken before exercise influence endurance performance and muscle fatigue during a running test in recreationally trained men.
Methods: This randomized, double-blind, placebo-controlled crossover pilot study compared the effects of a placebo and three different doses of dietary nitrate consumed before exercise. On separate occasions, participants completed the same treadmill running test to exhaustion after ingesting the assigned supplement. Measures of muscle performance, blood lactate concentration, and perceived exertion were collected before and after exercise to evaluate the effects of dietary nitrate supplementation.
Detailed description
Dietary nitrate (NO₃-), naturally present in vegetables such as beetroot and leafy greens, can be converted into nitric oxide (NO) through the nitrate-nitrite-NO pathway. Nitric oxide plays an important role in regulating blood flow, muscle contractility, mitochondrial efficiency, and oxygen utilization during exercise. For these reasons, dietary nitrate supplementation has attracted considerable interest as a nutritional strategy to enhance exercise performance.
Previous studies have reported improvements in endurance performance following acute dietary nitrate supplementation, particularly with doses between 5 and 9 mmol. However, the optimal dose for maximizing potential ergogenic effects remains uncertain, especially in recreationally trained individuals. Furthermore, limited evidence is available regarding the dose-response relationship between nitrate supplementation and exercise-induced neuromuscular fatigue.
This pilot study was designed to evaluate the acute effects of three different doses of dietary nitrate compared with placebo using a randomized, double-blind, placebo-controlled crossover design. Each participant completed four experimental trials, receiving placebo or one of three nitrate doses in a randomized order before performing an identical treadmill running test to exhaustion at the speed corresponding to the second ventilatory threshold (VT2). Neuromuscular performance, blood lactate concentration, and perceived exertion were assessed before and after exercise using standardized procedures.
The findings of this study are expected to contribute to a better understanding of the dose-response relationship of acute dietary nitrate supplementation and to support the design of larger clinical trials investigating its effects on endurance performance and neuromuscular function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo before exercise. |
| 4.8 mmol Dietary Nitrate | Experimental | Dietary Supplement: Dietary NitrateParticipants receive 4.8 mmol dietary nitrate before exercise. |
| 8.1 mmol Dietary Nitrate | Experimental | Dietary Supplement: Dietary NitrateParticipants receive 8.1 mmol dietary nitrate before exercise. |
| 11.3 mmol Dietary Nitrate | Experimental | Dietary Supplement: Dietary NitrateParticipants receive 11.3 mmol dietary nitrate before exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male adults aged 18 to 40 years.
- Recreationally trained, performing endurance or combined endurance/resistance exercise at least 3 times per week for the previous 6 months.
- Maximal oxygen uptake (VO₂max) consistent with recreational training status.
- Able to perform maximal treadmill running exercise.
- Willing and able to comply with all study procedures.
Key exclusion criteria (8 listed)
- Current smoking or use of nicotine products.
- History of cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal disorders that could affect exercise performance or participant safety.
- Current use of medications or dietary supplements known to influence nitric oxide metabolism or exercise performance (e.g., nitrate supplements, phosphodiesterase-5 inhibitors, antibacterial mouthwash).
- Allergy or intolerance to beetroot or any component of the study supplements.
- Following a vegetarian or vegan diet, or habitually consuming a high-nitrate diet.
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 |
|---|---|---|
| Dietary NitrateParticipants received a single acute dose of dietary nitrate before exercise. Three doses were evaluated (4.8 mmol, 8.1 mmol, and 11.3 mmol), administered approximately 2.5 hours before the treadmill running test. | Dietary supplement | 11.3 mmol Dietary Nitrate, 4.8 mmol Dietary Nitrate, 8.1 mmol Dietary Nitrate |
| PlaceboParticipants received a nitrate-depleted placebo beverage approximately 2.5 hours before the treadmill running test. | Other | Placebo |
Primary outcome
Time to Exhaustion (TTE)
Time frame: Baseline (single exercise session, approximately 2.5 hours after supplementation)
Time to exhaustion during a constant-speed treadmill running test performed at the speed corresponding to the second ventilatory threshold (VT2). Time was recorded in seconds from the start of the test until volitional exhaustion.
5 secondary outcomes
Countermovement Jump (CMJ) Height
Time frame: Immediately before supplementation exercise and immediately after exercise
Drop Jump (DJ) Height
Time frame: Immediately before exercise and immediately after exercise
Isometric Deadlift Peak Force
Time frame: Immediately before supplementation and immediately after exercise
Blood Lactate Concentration
Time frame: Immediately before exercise and immediately after exercise
Rating of Perceived Exertion (RPE)
Time frame: Immediately after exercise
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 30 Jul 2026.
- Background: PubMed 23640589Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.
- 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.
Helios Pareja Galeano study director
Universidad Autonoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Nitrate in people with Health Adult Subjects, run by Universidad Autonoma de Madrid at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 30 Jul 2026. 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 Spain. 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?
Time to Exhaustion (TTE) (time frame: Baseline (single exercise session, approximately 2.5 hours after supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735455, which also lists 1 linked publication.
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 30 Jul 2026.