NutritionNCT03449992
The Effects of Nitrate Supplementation on Elite Runners
A study testing nitrate-rich beetroot juice in people with Nutrition and Physical Performance, run by Universidad Autonoma de Madrid.
Trial summary
This study analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Physical Performance, Sport Physiology
- What is being tested?
- nitrate-rich beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 15 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Competing in national and international events
- Personal best in urban 10k: 33 minutes 0 seconds
Who cannot join
- Injury
About this study
Official title: The Effects of Beet-root Juice Supplementation on Exercise Economy, Rating of Perceived Exertion and Running Mechanics in Elite Distance Runners
This study analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners
Read the detailed description
This study analyzed the effects of 15 days beetroot juice supplementation on the VO2max, running economy, exercise perceived exertion, muscle power and locomotion mechanics in a group of 12 elite Spanish middle and long distance runners
- Conditions
- Nutrition, Physical Performance, Sport Physiology, Nitrates, Elite Athletes
- Being tested
- nitrate-rich beetroot juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate-rich beetroot juiceDietary supplement
Also called Beetroot juice
Nitrate-rich beetroot juice supplementation was administered for 15 consecutive days to participants in this arm
PlaceboDietary supplement
Placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this group ingested nitrate-rich beetroot juice for 15 days Receives: Dietary Supplement: nitrate-rich beetroot juice |
| Placebo group | Placebo comparator | Participants in this group ingested a placebo drink for 15 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running economy
The cost of running (oxygen consumption) at different speeds
Measured: Changes from baseline at 15 days
Secondary outcomes (5)
Time to exhaustion
Time that the athlete endured running until voluntarily ending the exercise
Measured: Changes from baseline at 15 days
Muscle power
Ability to produce muscle power in a jump test
Measured: Changes from baseline at 15 days
Muscle oxygenation
Saturation of O2 in the vastus lateralis during exercise
Measured: Changes from baseline at 15 days
RPE
Rate of perceived exertion during the exercise
Measured: Changes from baseline at 15 days
Running mechanics
Contact and flight time of each step during the exercise
Measured: Changes from baseline at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Nov 2016
- Primary completion10 Jan 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Parallel groups
- Model description
- Twelve elite distance runners were randomly assigned to either an intervention group or a placebo group. Participants in each group consumed beetroot juice or a placebo drink for 15 consecutive days.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Camilo Jose Cela University, Universidad Politecnica de Madrid
- Responsible party
- Principal investigator, Carlos Balsalobre-Fernández, Universidad Autonoma de Madrid
- Investigators
- Carlos Balsalobre-Fernández, PhD, Principal investigator, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449992
- Sponsor's protocol ID
- BEETRUN
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded database with data of the pre-post measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Beet-root Juice Supplementation on Exercise Economy, Rating of Perceived Exertion and Running Mechanics in Elite Distance Runners
- ClinicalTrials.gov ID
- NCT03449992
- Acronym / sponsor ID
- BEETRUN
- Conditions
- Nutrition, Physical Performance, Sport Physiology, Nitrates, Elite Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Camilo Jose Cela University, Universidad Politecnica de Madrid
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 1 Mar 2018 (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 analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners
Detailed description
This study analyzed the effects of 15 days beetroot juice supplementation on the VO2max, running economy, exercise perceived exertion, muscle power and locomotion mechanics in a group of 12 elite Spanish middle and long distance runners
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Twelve elite distance runners were randomly assigned to either an intervention group or a placebo group. Participants in each group consumed beetroot juice or a placebo drink for 15 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: nitrate-rich beetroot juiceParticipants in this group ingested nitrate-rich beetroot juice for 15 days |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group ingested a placebo drink for 15 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Competing in national and international events
- Personal best in urban 10k: 33 minutes 0 seconds
Key exclusion criteria (1 listed)
- Injury
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 beetroot juiceAlso: Beetroot juiceNitrate-rich beetroot juice supplementation was administered for 15 consecutive days to participants in this arm | Dietary supplement | Intervention group |
| PlaceboPlacebo drink | Dietary supplement | Placebo group |
Primary outcome
Running economy
Time frame: Changes from baseline at 15 days
The cost of running (oxygen consumption) at different speeds
5 secondary outcomes
Time to exhaustion
Time frame: Changes from baseline at 15 days
Muscle power
Time frame: Changes from baseline at 15 days
Muscle oxygenation
Time frame: Changes from baseline at 15 days
RPE
Time frame: Changes from baseline at 15 days
Running mechanics
Time frame: Changes from baseline at 15 days
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 1 Mar 2018.
- Individual participant dataSharing planned: Yes. Coded database with data of the pre-post measures will be made available
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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.
Carlos Balsalobre-Fernández, PhD principal investigator
Universidad Autonoma de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing nitrate-rich beetroot juice in people with Nutrition and Physical Performance, run by Universidad Autonoma de Madrid.
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 2 inclusion and 1 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Running economy (time frame: Changes from baseline at 15 days). 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 1 Mar 2018.