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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03101904
Other study ID # Jan 27 2016
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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