Exercise Nutritional Physiologynitrate_TTNCT02454049
Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes
A study testing beetroot juice, sodium nitrate and water in people with Exercise Nutritional Physiology, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Nutritional Physiology
- What is being tested?
- beetroot juice, sodium nitrate and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to Dec 2018
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy paracycling athletes
- healthy, able-bodied, upper-body trained individuals
Who cannot join
- female
- smoking
- any medication affecting performance
- medical conditions affecting performance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Influence of Dietary Nitrate on Paralympics 2016 Time Trial Performance in Swiss Elite Paracycling Athletes
The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.
Read the detailed description
The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.
- Conditions
- Exercise Nutritional Physiology
- Being tested
- beetroot juice, sodium nitrate, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beetroot juiceDietary supplement
6mmol nitrate
sodium nitrateDietary supplement
6mmol sodium nitrate
waterDietary supplement
plain water
| Study group | Role | What they receive |
|---|---|---|
| beetroot juice | Active comparator | beetroot juice containing 6mmol nitrate, ingested 3hours before the exercise test Receives: Dietary Supplement: beetroot juice |
| sodium nitrate | Active comparator | 6mmol sodium nitrate dissolved in plain water, ingested 3hours before the exercise test Receives: Dietary Supplement: sodium nitrate |
| water | Placebo comparator | 85ml of plain water, ingested 3 hours before the exercise test Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to perform trial
Measured: 3 hours after supplement ingestion
Secondary outcomes (1)
oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg
Measured: 3 hours after supplement ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2016
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Nutritional PhysiologyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, PD PhD, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454049
- Sponsor's protocol ID
- 2015-04
- Acronym
- nitrate_TT
- Status last verified
- Jan 2019
- First submitted
- 19 May 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary Nitrate on Paralympics 2016 Time Trial Performance in Swiss Elite Paracycling Athletes
- ClinicalTrials.gov ID
- NCT02454049
- Acronym / sponsor ID
- nitrate_TT / 2015-04
- Conditions
- Exercise Nutritional Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 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 aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.
Detailed description
The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beetroot juice | Active comparator | Dietary Supplement: beetroot juicebeetroot juice containing 6mmol nitrate, ingested 3hours before the exercise test |
| sodium nitrate | Active comparator | Dietary Supplement: sodium nitrate6mmol sodium nitrate dissolved in plain water, ingested 3hours before the exercise test |
| water | Placebo comparator | Dietary Supplement: water85ml of plain water, ingested 3 hours before the exercise test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy paracycling athletes
- healthy, able-bodied, upper-body trained individuals
Key exclusion criteria (4 listed)
- female
- smoking
- any medication affecting performance
- medical conditions affecting performance
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 |
|---|---|---|
| beetroot juice6mmol nitrate | Dietary supplement | beetroot juice |
| sodium nitrate6mmol sodium nitrate | Dietary supplement | sodium nitrate |
| waterplain water | Dietary supplement | water |
Primary outcome
time to perform trial
Time frame: 3 hours after supplement ingestion
1 secondary outcome
oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg
Time frame: 3 hours after supplement 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 18 Jan 2019.
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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.
Claudio Perret, PD PhD principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beetroot juice, sodium nitrate and water in people with Exercise Nutritional Physiology, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 4 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 18 Jan 2019. 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 Switzerland. 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 perform trial (time frame: 3 hours after supplement ingestion). 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 18 Jan 2019.