High Intensity Intermittent Sports PerformancePhase 4NITR-ITENCT02436629
Nitrate for High Intensity Intermittent Exercise
A Phase 4 study testing Nitrate-rich concentrated beetroot juice and Nitrate-depleted concentrated red beetroot juice in people with High Intensity Intermittent Sports Performance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High Intensity Intermittent Sports Performance
- What is being tested?
- Nitrate-rich concentrated beetroot juice and Nitrate-depleted concentrated red beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2015to Jul 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy P
- Players of the first two senior selection teams of a regional soccer club competing at the 3rd KNVB level or higher
- Training ≥2 days a week
- 18-40 years
- Male
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
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6200MD
About this study
Official title: The Effect of Nitrate Supplementation on Sport Performance: High Intensity Intermittent Performance in Recreational Athletes
The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players.
Read the detailed description
Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red beetroot juice has been shown to significantly lower blood pressure at rest and to improve exercise performance during cycle time trials. Furthermore, a positive exercise performance effect of nitrate ingestion has been observed in recreational athletes during intermittent exercise. However, this was achieved after acute supplementation with a substantial dose of dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved with a more conventional 6-day nitrate supplementation protocol with a lower daily dose remains to be established. Based on the gaps in current literature, our main goal will be to gain further insight into the effects of a 6-day nitrate supplementation protocol on high intensity intermittent exercise performance in recreational athletes.
- Being tested
- Nitrate-rich concentrated beetroot juice, Nitrate-depleted concentrated red beetroot juice
- Keywords
- Red beetroot juice, High intensity intermittent exercise, Nitrite, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich concentrated beetroot juiceDietary supplement
James White, Beet It Sport Shot, 70ml (Standard)
Nitrate-depleted concentrated red beetroot juiceDietary supplement
Beet It Sport Shot, 70ml (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich concentrated beetroot juice | Active comparator | Dietary supplement: 800 mg of nitrate in 140 mL of concentrated beetroot juice (Beet-IT) Receives: Dietary Supplement: Nitrate-rich concentrated beetroot juice |
| Nitrate-depleted conc. beetroot juice | Placebo comparator | Placebo: 140 mL of nitrate-depleted concentrated red beetroot juice Receives: Dietary Supplement: Nitrate-depleted concentrated red beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total distance covered during the Yo-Yo Intermittent Recovery 1 test (Yo-Yo IR1 test)
Measured: Performance 3 hours post red beetroot juice ingestion
Secondary outcomes (2)
Plasma concentration of nitrite and nitrate
Measured: Concetrations 3 hours post red beetroot juice ingestion
Salivary concentration of nitrite and nitrate
Measured: Concetrations 3 hours post red beetroot juice ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Intensity Intermittent Sports 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT02436629
- Sponsor's protocol ID
- METC 153006
- Acronym
- NITR-ITE
- Status last verified
- Mar 2016
- First submitted
- 4 May 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wylie LJ, Mohr M, Krustrup P, Jackman SR, Ermiotadis G, Kelly J, Black MI, Bailey SJ, Vanhatalo A, Jones AM. Dietary nitrate supplementation improves team sport-specific intense intermittent exercise performance. Eur J Appl Physiol. 2013 Jul;113(7):1673-84. doi: 10.1007/s00421-013-2589-8. Epub 2013 Feb 1.
PubMed 23370859Bond H, Morton L, Braakhuis AJ. Dietary nitrate supplementation improves rowing performance in well-trained rowers. Int J Sport Nutr Exerc Metab. 2012 Aug;22(4):251-6. doi: 10.1123/ijsnem.22.4.251. Epub 2012 Jun 15.
PubMed 22710356Cermak 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 22248502Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. doi: 10.2165/00007256-200838010-00004.
PubMed 18081366
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrate Supplementation on Sport Performance: High Intensity Intermittent Performance in Recreational Athletes
- ClinicalTrials.gov ID
- NCT02436629
- Acronym / sponsor ID
- NITR-ITE / METC 153006
- Keywords
- Red beetroot juice, High intensity intermittent exercise, Nitrite, Soccer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 May 2015 (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 objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players.
Detailed description
Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red beetroot juice has been shown to significantly lower blood pressure at rest and to improve exercise performance during cycle time trials. Furthermore, a positive exercise performance effect of nitrate ingestion has been observed in recreational athletes during intermittent exercise. However, this was achieved after acute supplementation with a substantial dose of dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved with a more conventional 6-day nitrate supplementation protocol with a lower daily dose remains to be established. Based on the gaps in current literature, our main goal will be to gain further insight into the effects of a 6-day nitrate supplementation protocol on high intensity intermittent exercise performance in recreational athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich concentrated beetroot juice | Active comparator | Dietary Supplement: Nitrate-rich concentrated beetroot juiceDietary supplement: 800 mg of nitrate in 140 mL of concentrated beetroot juice (Beet-IT) |
| Nitrate-depleted conc. beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-depleted concentrated red beetroot juicePlacebo: 140 mL of nitrate-depleted concentrated red beetroot juice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy P
- Players of the first two senior selection teams of a regional soccer club competing at the 3rd KNVB level or higher
- Training ≥2 days a week
- 18-40 years
- Male
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 |
|---|---|---|
| Nitrate-rich concentrated beetroot juiceJames White, Beet It Sport Shot, 70ml (Standard) | Dietary supplement | Nitrate-rich concentrated beetroot juice |
| Nitrate-depleted concentrated red beetroot juiceBeet It Sport Shot, 70ml (Placebo) | Dietary supplement | Nitrate-depleted conc. beetroot juice |
Primary outcome
Total distance covered during the Yo-Yo Intermittent Recovery 1 test (Yo-Yo IR1 test)
Time frame: Performance 3 hours post red beetroot juice ingestion
2 secondary outcomes
Plasma concentration of nitrite and nitrate
Time frame: Concetrations 3 hours post red beetroot juice ingestion
Salivary concentration of nitrite and nitrate
Time frame: Concetrations 3 hours post red beetroot juice ingestion
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 6 Jul 2016.
- Background: PubMed 23370859Wylie LJ, Mohr M, Krustrup P, Jackman SR, Ermiotadis G, Kelly J, Black MI, Bailey SJ, Vanhatalo A, Jones AM. Dietary nitrate supplementation improves team sport-specific intense intermittent exercise performance. Eur J Appl Physiol. 2013 Jul;113(7):1673-84. doi: 10.1007/s00421-013-2589-8. Epub 2013 Feb 1.
- Background: PubMed 22710356Bond H, Morton L, Braakhuis AJ. Dietary nitrate supplementation improves rowing performance in well-trained rowers. Int J Sport Nutr Exerc Metab. 2012 Aug;22(4):251-6. doi: 10.1123/ijsnem.22.4.251. Epub 2012 Jun 15.
- 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 18081366Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. doi: 10.2165/00007256-200838010-00004.
- Individual participant dataSharing planned: No
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrate-rich concentrated beetroot juice and Nitrate-depleted concentrated red beetroot juice in people with High Intensity Intermittent Sports Performance, run by Maastricht University Medical Center at 1 site 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 5 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 6 Jul 2016. 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 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?
Total distance covered during the Yo-Yo Intermittent Recovery 1 test (Yo-Yo IR1 test) (time frame: Performance 3 hours post red beetroot juice ingestion). 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 NCT02436629, which also lists 4 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 6 Jul 2016.