HypoxiaNCT01795534
Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
A study of Hypoxia, run by Bangor University at 1 site in United Kingdom.
Trial summary
The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trained athletes with personal best performances for a 10km run of sub 40 minutes
Who cannot join
- Unable to give informed consent Unstable medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.
- Conditions
- Hypoxia
- Being tested
- Beetroot shot then placebo shot, Placebo shot then beetroot shot
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot shot then placebo shotDietary supplement
Beetroot shot, four day wash out, then placebo shot
Placebo shot then beetroot shotDietary supplement
Placebo shot, four day wash out, then beetroot shot
| Study group | Role | What they receive |
|---|---|---|
| Beetroot shot then placebo shot | Experimental | Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).
Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK) Receives: Dietary Supplement: Beetroot shot then placebo shot |
| Placebo shot then beetroot shot | Placebo comparator | Intervention: Participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).
Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). Receives: Dietary Supplement: Placebo shot then beetroot shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete a 10 km Run
Time taken following consumption of beetroot shot or consumption of placebo shot
Measured: Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie H Macdonald, PhD, Principal investigator, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795534
- Sponsor's protocol ID
- Jan 13
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2013
- Last updated
- 19 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
- ClinicalTrials.gov ID
- NCT01795534
- Acronym / sponsor ID
- Jan 13
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot shot then placebo shot | Experimental | Dietary Supplement: Beetroot shot then placebo shotIntervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK) |
| Placebo shot then beetroot shot | Placebo comparator | Dietary Supplement: Placebo shot then beetroot shotIntervention: Participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trained athletes with personal best performances for a 10km run of sub 40 minutes
Key exclusion criteria (1 listed)
- Unable to give informed consent Unstable medical condition.
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 shot then placebo shotBeetroot shot, four day wash out, then placebo shot | Dietary supplement | Beetroot shot then placebo shot |
| Placebo shot then beetroot shotPlacebo shot, four day wash out, then beetroot shot | Dietary supplement | Placebo shot then beetroot shot |
Primary outcome
Time to Complete a 10 km Run
Time frame: Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)
Time taken following consumption of beetroot shot or consumption of placebo shot
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jamie H Macdonald, PhD principal investigator
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypoxia, run by Bangor University at 1 site in United Kingdom.
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 1 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 19 Jul 2017. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Complete a 10 km Run (time frame: Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)). 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 19 Jul 2017.