Time-trial PerformancePhase 4NO-howNCT02115893
Nitrate Supplementation; Duration
A Phase 4 study testing Sodium Nitrate and Sodium Chloride in people with Time-trial Performance and Submaximal Exercise Performance, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Time-trial Performance, Submaximal Exercise Performance, Nitrite
- What is being tested?
- Sodium Nitrate and Sodium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 4
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18.5 < BMI < 25 kg/m2
- Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)
- VO2max ≥ 55 mL/kg/min
Who cannot join
- Use of medication
- Injury prohibiting them from performing the exercise protocol effectively
- Smoking
- Currently supplementing diet with nitrate
- Lactose intolerance
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University Medical Centre+
Maastricht, Limburg, 6200 MD
Maastricht University Medical Centre+
Maastricht, Limburg, 6200MD
About this study
Official title: The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation
The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.
Read the detailed description
Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.
- Being tested
- Sodium Nitrate, Sodium Chloride
- Keywords
- Nitrate, Performance, Sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitrateDietary supplement
Sodium ChlorideDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sodium Nitrate | Active comparator | Dietary Supplement: Sodium nitrate 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany) Receives: Dietary Supplement: Sodium Nitrate |
| Sodium Cloride | Placebo comparator | Dietary Supplement: Sodium chloride 800 mg of sodium chloride added with water to get a 140 mL solution (Frisia Zout BV, Harlingen, The Netherlands) Receives: Dietary Supplement: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-trial exercise performance
The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion
Measured: Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)
Secondary outcomes (4)
Resting blood pressure
Resting blood pressure measures following ingestion of dietary nitrate
Measured: 30 min pre-ingestion until 2.5 hours post-ingestion
Plasma nitrate and nitrite levels
Plasma nitrate and nitrite levels following ingestion of dietary nitrate
Measured: 30 min pre-ingestion until 30 min post-time-trial testing
Submaximal exercise performance
Oxygen consumption CO2 production and heart rate during submaximal exercise
Measured: starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise
Time-trial exercise performance; power output and heart rate
Power output and heart rate during the time-trial exercise
Measured: starting from 4 hours post-ingestion on testing days until completion of the time-trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Time-trial PerformanceStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lex B Verdijk, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115893
- Sponsor's protocol ID
- METC13-3-059
- Acronym
- NO-how
- Status last verified
- Oct 2014
- First submitted
- 10 Apr 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- 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 23640589Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64.
PubMed 22248502Bescos R, Sureda A, Tur JA, Pons A. The effect of nitric-oxide-related supplements on human performance. Sports Med. 2012 Feb 1;42(2):99-117. doi: 10.2165/11596860-000000000-00000.
PubMed 22260513
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation
- ClinicalTrials.gov ID
- NCT02115893
- Acronym / sponsor ID
- NO-how / METC13-3-059
- Keywords
- Nitrate, Performance, Sports
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.
Detailed description
Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Nitrate | Active comparator | Dietary Supplement: Sodium NitrateDietary Supplement: Sodium nitrate 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany) |
| Sodium Cloride | Placebo comparator | Dietary Supplement: Sodium ChlorideDietary Supplement: Sodium chloride 800 mg of sodium chloride added with water to get a 140 mL solution (Frisia Zout BV, Harlingen, The Netherlands) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18.5 < BMI < 25 kg/m2
- Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)
- VO2max ≥ 55 mL/kg/min
Key exclusion criteria (5 listed)
- Use of medication
- Injury prohibiting them from performing the exercise protocol effectively
- Smoking
- Currently supplementing diet with nitrate
- Lactose intolerance
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 |
|---|---|---|
| Sodium Nitrate | Dietary supplement | Sodium Nitrate |
| Sodium Chloride | Dietary supplement | Sodium Cloride |
Primary outcome
Time-trial exercise performance
Time frame: Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)
The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion
4 secondary outcomes
Resting blood pressure
Time frame: 30 min pre-ingestion until 2.5 hours post-ingestion
Plasma nitrate and nitrite levels
Time frame: 30 min pre-ingestion until 30 min post-time-trial testing
Submaximal exercise performance
Time frame: starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise
Time-trial exercise performance; power output and heart rate
Time frame: starting from 4 hours post-ingestion on testing days until completion of the time-trial
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 16 Mar 2016.
- 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.
- Background: PubMed 22248502Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64.
- Background: PubMed 22260513Bescos R, Sureda A, Tur JA, Pons A. The effect of nitric-oxide-related supplements on human performance. Sports Med. 2012 Feb 1;42(2):99-117. doi: 10.2165/11596860-000000000-00000.
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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.
Lex B Verdijk, PhD principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Nitrate and Sodium Chloride in people with Time-trial Performance and Submaximal Exercise Performance, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 3 inclusion and 5 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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-trial exercise performance (time frame: Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)). 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 NCT02115893, which also lists 3 linked publications.
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 16 Mar 2016.