Back to resultsThe Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beetroot Juice
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia
Eligibility Criteria
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.
Sites / Locations
- School of Sport, Health and Exercise Sciences, Bangor University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitrate then Placebo
Placebo then Nitrate
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hypoxic Exercise Performance as assessed by time to exhaustion at 80% of hypoxic V̇O2max reserve.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03101904
Brief Title
The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Official Title
The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bangor University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrate then Placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo then Nitrate
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice
Other Intervention Name(s)
Nitrate-rich beetroot juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nitrate-depleted beetroot juice
Primary Outcome Measure Information:
Title
Acute Mountain Sickness (AMS-C) as assessed by the Environmental Symptoms Questionnaire.
Description
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.
Time Frame
Measured on the fifth day of supplementation with a six-hour exposure to hypoxia
Secondary Outcome Measure Information:
Title
Hypoxic Exercise Performance as assessed by time to exhaustion at 80% of hypoxic V̇O2max reserve.
Description
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).
Time Frame
Measured on the sixth day of supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie H Macdonald, PhD
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Sport, Health and Exercise Sciences, Bangor University
City
Bangor
State/Province
Gwynedd
ZIP/Postal Code
LL57 2PZ
Country
United Kingdom
12. IPD Sharing Statement
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The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
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