HypoxiaNCT03101904

The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia

A study testing Beetroot Juice in people with Hypoxia, run by Bangor University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study will aim to describe and evaluate the effect of chronic beetroot juice supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It is hypothesized that beetroot supplementation will decrease acute mountain sickness and increase exercise performance. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypoxia
What is being tested?: Beetroot Juice
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2016to 10 Jan 2017
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Women only: Regular menstrual cycle or post-menopausal

Who cannot join

Stayed at altitude above 2500m in the last 6 months
Traveled to altitude above 2500m in the last 2 months
Unable to give informed consent
Unstable medical condition.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

School of Sport, Health and Exercise Sciences, Bangor University
Bangor, Gwynedd, LL57 2PZ

Other trials in United Kingdom

About this study

Conditions: Hypoxia
Being tested: Beetroot Juice, Placebo
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beetroot JuiceDietary supplement
Also called Nitrate-rich beetroot juice
PlaceboDietary supplement
Also called Nitrate-depleted beetroot juice

Study groups in NCT03101904
Study group	Role	What they receive
Nitrate then Placebo	Experimental	Participants will consume a daily a beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Following a minimum of ten days wash out, participants will then consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Receives: Dietary Supplement: Beetroot Juice; Dietary Supplement: Placebo
Placebo then Nitrate	Placebo comparator	Participants will consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Following a minimum of ten days wash out, participants will then consume a daily beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Receives: Dietary Supplement: Beetroot Juice; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.
Acute Cerebral Mountain Sickness score (AMS-C) calculated from the 11-item Environmental Symptoms Questionnaire (ESQ; Sampson et al., 1994). Participants rate the severity of each item from zero to five, and the ratings were multiplied by their factorial loadings and summed.
Unabbreviated scale title: Acute Cerebral Mountain Sickness Abbreviated title: AMS-C Unit of measure: Scores on a scale Minimum value: 0 Maximum value: 5 Interpretation: Higher scores mean a worse outcome
Measured: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia

Secondary outcomes (1)

Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.
On day six of each supplementation protocol, participants completed a time to exhaustion test at 80% of their hypoxic V̇O2max reserve in acute hypoxia (FiO2 14.1%, equivalent 3225 m). Maximal exercise performance is defined as time to exhaustion (TTE) determined by the time from onset of test to task failure (volitional exhaustion or inability to maintain treadmill speed).
Measured: Measured on the sixth day of supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201610 Jan 2017

First posted5 Apr 2017
Study startFeb 2016
Primary completion9 Jan 2017
Study completion10 Jan 2017

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.
Publications (1)Papers the sponsor has linked to this study.
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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03101904
Sponsor's protocol ID: Jan 27 2016
Status last verified: Feb 2025
First submitted: 10 Mar 2016
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sampson JB, Kobrick JL, Johnson RF. Measurement of subjective reactions to extreme environments: the Environmental Symptoms Questionnaire. Military Psychology. 1994; 6(4):215-233. doi: 10.1207/s15327876mp0604_2

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
ClinicalTrials.gov ID: NCT03101904
Acronym / sponsor ID: Jan 27 2016
Conditions: Hypoxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Bangor UniversityUniversity, hospital or other
Study start: Feb 2016
Primary completion: 9 Jan 2017 (actual)
Study completion: 10 Jan 2017 (actual)
First posted: 5 Apr 2017 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nitrate then Placebo	Experimental	Dietary Supplement: Beetroot Juice, Dietary Supplement: PlaceboParticipants will consume a daily a beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Following a minimum of ten days wash out, participants will then consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).
Placebo then Nitrate	Placebo comparator	Dietary Supplement: Beetroot Juice, Dietary Supplement: PlaceboParticipants will consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). Following a minimum of ten days wash out, participants will then consume a daily beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Women only: Regular menstrual cycle or post-menopausal

Key exclusion criteria (4 listed)

Stayed at altitude above 2500m in the last 6 months
Traveled to altitude above 2500m in the last 2 months
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 JuiceAlso: Nitrate-rich beetroot juice	Dietary supplement	Nitrate then Placebo, Placebo then Nitrate
PlaceboAlso: Nitrate-depleted beetroot juice	Dietary supplement	Nitrate then Placebo, Placebo then Nitrate

Primary outcome

Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.
Time frame: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia
Acute Cerebral Mountain Sickness score (AMS-C) calculated from the 11-item Environmental Symptoms Questionnaire (ESQ; Sampson et al., 1994). Participants rate the severity of each item from zero to five, and the ratings were multiplied by their factorial loadings and summed. Unabbreviated scale title: Acute Cerebral Mountain Sickness Abbreviated title: AMS-C Unit of measure: Scores on a scale Minimum value: 0 Maximum value: 5 Interpretation: Higher scores mean a worse outcome

1 secondary outcome

Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.
Time frame: Measured on the sixth day of supplementation

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nitrate First, Then Placebo	13	13
Placebo First, Then Nitrate	10	10

Primary outcome: Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.

Time frame: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia. Mean (Standard Error). Unit: scores on a scale

Measure	Nitrate n = 20	Placebo n = 20
Value	0.36 (0.09)	0.21 (0.04)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse even data was collected throughout participant involvement in the study. Adverse even data was collected 2 hours and 48 hours after each laboratory visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nitrate	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationSampson JB, Kobrick JL, Johnson RF. Measurement of subjective reactions to extreme environments: the Environmental Symptoms Questionnaire. Military Psychology. 1994; 6(4):215-233. doi: 10.1207/s15327876mp0604_2

Related trials for Hypoxia

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia

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 testing Beetroot Juice in people with 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 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 26 Feb 2025. 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 26 Feb 2025). 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?

Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire. (time frame: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia). 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 NCT03101904, which also lists 1 linked publication.

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 26 Feb 2025.