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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate then Placebo | Experimental | 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). |
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| Placebo then Nitrate | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot Juice | Dietary Supplement |
|
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| 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 zero to five, and the ratings were multiplied by their factorial loadings and summed. Unabbreviated scale title: Acute Cerebral Mountain Sickness Abbreviated title: AMS-C Unit of measure: Scores on a scale Minimum value: 0 Maximum value: 5 Interpretation: Higher scores mean a worse outcome | Measured on the fifth day of supplementation with a six-hour exposure to hypoxia |
| 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 completed 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie H Macdonald, PhD | Bangor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Sport, Health and Exercise Sciences, Bangor University | Bangor | Gwynedd | LL57 2PZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Sampson JB, Kobrick JL, Johnson RF. Measurement of subjective reactions to extreme environments: the Environmental Symptoms Questionnaire. Military Psychology. 1994; 6(4):215-233. doi: 10.1207/s15327876mp0604_2 |
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Participants completed a baseline demographics visit including the following assessments:
Participants then completed a minimum 48 h wash out
Participants completed a hypoxic VO2max test at 14.1% O2
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitrate First, 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). 10 day wash out. 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). |
| FG001 | Placebo First, 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). 10 day wash out. 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Days) |
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| Wash Out (10 Days) |
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| Second Intervention (6 Days) |
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Analysis population is different from overall number because it does not include the 3 participants that did not complete the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitrate First, Then Placebo | Participants consumed 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). 10 day wash out After a minimum 10-day wash-out, participants consumed 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 zero to five, and the ratings were multiplied by their factorial loadings and summed. Unabbreviated scale title: Acute Cerebral Mountain Sickness Abbreviated title: AMS-C Unit of measure: Scores on a scale Minimum value: 0 Maximum value: 5 Interpretation: Higher scores mean a worse outcome | Posted | Mean | Standard Error | scores on a scale | Measured on the fifth day of supplementation with a six-hour exposure to hypoxia |
|
Adverse even data was collected throughout participant involvement in the study. Adverse even data was collected 2 hours and 48 hours after each laboratory visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitrate | Participants consumed 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Possible inter-costal muscle strain or pericarditis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jamie Hugo Macdonald | Bangor Univeristy | +44 1248 38 | 3272 | j.h.macdonald@bangor.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2015 | Apr 28, 2020 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2016 | Apr 28, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement |
|
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| Measured on the sixth day of supplementation |
| NOT COMPLETED |
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| AMS Trial (Day 5) |
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| Performance Trial (Day 6) |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Placebo First, Then Nitrate | Participants consumed 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). 10 day wash out After a minimum 10-day wash-out, participants consumed 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Maximal Aerobic Capacity | Mean | Standard Deviation | ml/kg/min |
|
| OG001 | Placebo | Participants consumed 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). |
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| Secondary | Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve. | On day six of each supplementation protocol, participants completed 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). | Five participants did not complete the TTE on day 6 because of injury or technical reasons, e.g., cramp or tripping while on the treadmill, and one of these was also removed from analyses relating to RPE on day 5 because of failure to use the RPE scale consistently. | Posted | Mean | Standard Deviation | seconds | Measured on the sixth day of supplementation |
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| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Placebo | Participants consumed 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). | 0 | 20 | 0 | 20 | 0 | 20 |
|
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