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Completed

NCT Number: NCT03101904

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

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Sport, Health and Exercise Sciences, Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women only: Regular menstrual cycle or post-menopausal

Exclusion criteria

  • 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.

Treatment and study plan

Beetroot juice

Dietary Supplement

Other names: Nitrate-rich beetroot juice

Placebo

Dietary Supplement

Other names: Nitrate-depleted beetroot juice

Primary outcomes

  1. 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

Secondary outcomes

  1. Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.

    Time frame: Measured on the sixth day of supplementation

    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).

Sponsors and collaborators

Lead sponsor

Bangor University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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