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Clinical Trials/NCT03101904
NCT03101904CompletedNot Applicable

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

Bangor University2 sites in 1 country23 target enrollmentStarted: February 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
2
Primary Endpoint
Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

  • Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.(Measured on the sixth day of supplementation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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