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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypoxia

Intervention / Treatment
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* Dietary Supplement: Beetroot Juice
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrate then Placebo<br>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: Beetroot Juice<br> <br> * Other names: Nitrate-rich beetroot juice;Dietary Supplement: Placebo<br> <br> * Other names: Nitrate-depleted beetroot juice;|
| Placebo Comparator: Placebo then Nitrate<br>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: Beetroot Juice<br> <br> * Other names: Nitrate-rich beetroot juice;Dietary Supplement: Placebo<br> <br> * Other names: Nitrate-depleted beetroot juice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Measured on the sixth day of supplementation |