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

March 30, 2017 updated by: Bangor University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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 one to five, and the ratings were multiplied by their factorial loadings and summed.
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.
Time Frame: Measured on the sixth day of supplementation
On day six of each supplementation protocol, participants complet 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

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 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)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jan 27 2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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