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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Beetroot Juice

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrate then Placebo; 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).	Dietary supplement: Placebo; Other Names: Nitrate-depleted beetroot juice; Dietary supplement: Beetroot Juice; Other Names: Nitrate-rich beetroot juice
Placebo Comparator: Placebo then Nitrate; 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).	Dietary supplement: Placebo; Other Names: Nitrate-depleted beetroot juice; Dietary supplement: Beetroot Juice; Other Names: Nitrate-rich beetroot juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 on the fifth day of supplementation with a six-hour exposure to hypoxia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 on the sixth day of supplementation

Collaborators and Investigators

• Sponsor: Bangor University
• Investigators: Principal Investigator: Jamie H Macdonald, PhD, Bangor University

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 9, 2017
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Hypoxia; Altitude Sickness
• Other Study ID Numbers: Jan 27 2016