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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101904
• Other study ID #: Jan 27 2016
• Status: Completed
• Phase: N/A
• First received: March 10, 2016
• Last updated: March 30, 2017
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Bangor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia

Intervention

Dietary Supplement:
• Beetroot Juice

• Placebo

Locations

Country	Name	City	State
United Kingdom	School of Sport, Health and Exercise Sciences, Bangor University	Bangor	Gwynedd

Sponsors (1)

Lead Sponsor	Collaborator
Bangor University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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	Hypoxic Exercise Performance as assessed by time to exhaustion at 80% of hypoxic V?O2max reserve.	On day six of each supplementation protocol, participants complet a time to exhaustion test at 80% of their hypoxic V?O2max 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