HealthyNCT01961427
Dose and Response of Dietary Nitrate in Healthy and Active Men
A study testing sodium nitrate and Beetroot juice in people with Healthy, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement. It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sodium nitrate and Beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Nov 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 45
- healthy active men
- non-smoking
Who cannot join
- medication intake during study phase
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Dose and Response of Dietary and Inorganic Nitrate in Healthy and Active Men
It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.
It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.
Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.
Read the detailed description
- The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.
- The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.
- Conditions
- Healthy
- Being tested
- sodium nitrate, Beetroot juice
- Keywords
- dietary nitrate, beetroot juice, exercise performance, oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium nitrateDietary supplement
Also called Inorganic nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
Beetroot juiceDietary supplement
Also called Biotta beetroot juice shot
concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
| Study group | Role | What they receive |
|---|---|---|
| sodium Nitrate 12mmol | Active comparator | Ingestion of a solution of inorganic nitrate, dosage: 12mmol Receives: Dietary Supplement: sodium nitrate |
| sodium Nitrate (6mmol) | Active comparator | ingestion of inorganic nitrate (6mmol solution) Receives: Dietary Supplement: sodium nitrate |
| sodium nitrate 3mmol | Active comparator | ingestion of inorganic nitrate (3mmol solution) Receives: Dietary Supplement: sodium nitrate |
| sodium nitrate (0mmol) | Active comparator | Ingestion of water as a placebo Receives: Dietary Supplement: sodium nitrate |
| Beetroot juice (12mmol) | Active comparator | ingestion of 170ml of concentrated beetroot juice (12mmol) Receives: Dietary Supplement: Beetroot juice |
| beetroot juice (6mmol) | Active comparator | ingestion of 85ml concentrated beetroot juice (6mmol) Receives: Dietary Supplement: Beetroot juice |
| Beetroot juice (3mmol) | Active comparator | Ingestion of 42.5ml of concentrated beetroot juice (3mmol) Receives: Dietary Supplement: Beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption
Oxygen consumption during exercise protocol
Measured: 30min
Secondary outcomes (5)
Blood pressure
every hour, blood pressure is measured.
Measured: 6 hours
oxygen saturation
every hour oxygen saturation is measured.
Measured: 6 hours
Rating of perceived exertion (RPE)
RPE is measured after the low-intensity exercise performance and after the submaximal exercise performance.
Measured: during the 7 weeks of study phase
Heart rate
Heart rate is measured before the ingestion, before the exercise test and during the exercise test. resting heart rate is additionally measured every hours after the intake of dietary/inorganic nitrate.
Measured: during the 7 weeks of study phase
Nitrate and nitrite concentration
every hour for the six hours after the ingestion of dietary/inorganic nitrate, nitrate and nitrite concentration in the blood is analyzed.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, Dr. sc. nat., Principal investigator, Sportmedizin Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961427
- Sponsor's protocol ID
- 2013-12
- Status last verified
- Nov 2016
- First submitted
- 9 Oct 2013
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose and Response of Dietary and Inorganic Nitrate in Healthy and Active Men
- ClinicalTrials.gov ID
- NCT01961427
- Acronym / sponsor ID
- 2013-12
- Conditions
- Healthy
- Keywords
- dietary nitrate, beetroot juice, exercise performance, oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- University of Zurich
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Oct 2013 (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.
It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.
It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.
Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.
Detailed description
- The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.
- The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| sodium Nitrate 12mmol | Active comparator | Dietary Supplement: sodium nitrateIngestion of a solution of inorganic nitrate, dosage: 12mmol |
| sodium Nitrate (6mmol) | Active comparator | Dietary Supplement: sodium nitrateingestion of inorganic nitrate (6mmol solution) |
| sodium nitrate 3mmol | Active comparator | Dietary Supplement: sodium nitrateingestion of inorganic nitrate (3mmol solution) |
| sodium nitrate (0mmol) | Active comparator | Dietary Supplement: sodium nitrateIngestion of water as a placebo |
| Beetroot juice (12mmol) | Active comparator | Dietary Supplement: Beetroot juiceingestion of 170ml of concentrated beetroot juice (12mmol) |
| beetroot juice (6mmol) | Active comparator | Dietary Supplement: Beetroot juiceingestion of 85ml concentrated beetroot juice (6mmol) |
| Beetroot juice (3mmol) | Active comparator | Dietary Supplement: Beetroot juiceIngestion of 42.5ml of concentrated beetroot juice (3mmol) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 to 45
- healthy active men
- non-smoking
Key exclusion criteria (1 listed)
- medication intake during study phase
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 nitrateAlso: Inorganic nitrateIngestion of 3mmol, 6mmol and 12mmol sodium nitrate | Dietary supplement | sodium Nitrate (6mmol), sodium Nitrate 12mmol, sodium nitrate (0mmol), sodium nitrate 3mmol |
| Beetroot juiceAlso: Biotta beetroot juice shotconcentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol) | Dietary supplement | Beetroot juice (12mmol), Beetroot juice (3mmol), beetroot juice (6mmol) |
Primary outcome
oxygen consumption
Time frame: 30min
Oxygen consumption during exercise protocol
5 secondary outcomes
Blood pressure
Time frame: 6 hours
oxygen saturation
Time frame: 6 hours
Rating of perceived exertion (RPE)
Time frame: during the 7 weeks of study phase
Heart rate
Time frame: during the 7 weeks of study phase
Nitrate and nitrite concentration
Time frame: 6 hours
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 21 Nov 2016.
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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, Dr. sc. nat. principal investigator
Sportmedizin Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium nitrate and Beetroot juice in people with Healthy, 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 3 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 21 Nov 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 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. 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?
oxygen consumption (time frame: 30min). 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 21 Nov 2016.