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

NCT ID: NCT03101904

Last Updated: 2025-02-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

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).

Group Type PLACEBO_COMPARATOR

Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nitrate-rich beetroot juice Nitrate-depleted beetroot juice

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bangor University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie H Macdonald, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangor University

Locations

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School of Sport, Health and Exercise Sciences, Bangor University

Bangor, Gwynedd, United Kingdom

Site Status

Countries

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United Kingdom

References

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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

Reference Type RESULT

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Jan 27 2016

Identifier Type: -

Identifier Source: org_study_id

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