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

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ClinicalTrials.gov Identifier: NCT03101904
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Bangor University

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.

Condition or disease Intervention/treatment Phase
Hypoxia Dietary Supplement: Beetroot Juice Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Study Start Date : February 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitrate then Placebo

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
Other Name: Nitrate-rich beetroot juice

Dietary Supplement: Placebo
Other Name: Nitrate-depleted beetroot juice

Placebo Comparator: Placebo then Nitrate

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
Other Name: Nitrate-rich beetroot juice

Dietary Supplement: Placebo
Other Name: Nitrate-depleted beetroot juice




Primary Outcome Measures :
  1. 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 one to five, and the ratings were multiplied by their factorial loadings and summed.


Secondary Outcome Measures :
  1. Hypoxic Exercise Performance as assessed by time to exhaustion at 80% of hypoxic V̇O2max reserve. [ Time Frame: Measured on the sixth day of supplementation ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101904


Locations
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United Kingdom
School of Sport, Health and Exercise Sciences, Bangor University
Bangor, Gwynedd, United Kingdom, LL57 2PZ
Sponsors and Collaborators
Bangor University
Investigators
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Principal Investigator: Jamie H Macdonald, PhD Bangor University

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Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT03101904     History of Changes
Other Study ID Numbers: Jan 27 2016
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Altitude Sickness
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases