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

NCT03101904 | Completed Results

• 1 other identifier: Jan 27 2016
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Measured on the sixth day of supplementation

Study Arms (2)

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).

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).

Dietary Supplement: Beetroot Juice; Dietary Supplement: Placebo

Interventions

Beetroot Juice DIETARY_SUPPLEMENT

Also known as: Nitrate-rich beetroot juice

Nitrate then Placebo; Placebo then Nitrate

Placebo DIETARY_SUPPLEMENT

Also known as: Nitrate-depleted beetroot juice

Nitrate then Placebo; Placebo then Nitrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women only: Regular menstrual cycle or post-menopausal

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangor University: lead

Study Sites (1)

School of Sport, Health and Exercise Sciences, Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Jamie Hugo Macdonald
• Organization: Bangor Univeristy

j.h.macdonald@bangor.ac.uk

+44 1248 38

Study Officials

• Jamie H Macdonald, PhD

  Bangor University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 5, 2017
• Study Start: February 1, 2016
• Primary Completion: January 9, 2017
• Study Completion: January 10, 2017
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Locations

GB (1)