Trial Outcomes & Findings for The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia (NCT NCT03101904)

NCT ID: NCT03101904

Last Updated: 2025-02-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Measured on the fifth day of supplementation with a six-hour exposure to hypoxia

Results posted on

2025-02-26

Participant Flow

1. Participants completed a baseline demographics visit including the following assessments: * Age * Height * Body mass * Blood pressure * Haemoglobin * Normoxic VO2max (maximal exercise) test 2. Participants then completed a minimum 48 h wash out 3. Participants completed a hypoxic VO2max test at 14.1% O2

Participant milestones

Participant milestones
Measure	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).	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).
First Intervention (6 Days) STARTED	13	10
First Intervention (6 Days) Baseline Bloods (Day 1)	13	10
First Intervention (6 Days) AMS Trial (Day 5)	13	10
First Intervention (6 Days) Performance Trial (Day 6)	13	10
First Intervention (6 Days) COMPLETED	13	10
First Intervention (6 Days) NOT COMPLETED	0	0
Wash Out (10 Days) STARTED	13	10
Wash Out (10 Days) COMPLETED	10	10
Wash Out (10 Days) NOT COMPLETED	3	0
Second Intervention (6 Days) STARTED	10	10
Second Intervention (6 Days) Baseline Bloods (Day 1)	10	10
Second Intervention (6 Days) AMS Trial (Day 5)	10	10
Second Intervention (6 Days) Performance Trial (Day 6)	10	10
Second Intervention (6 Days) COMPLETED	10	10
Second Intervention (6 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Wash Out (10 Days) Adverse Event	1	0
Wash Out (10 Days) Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrate First, Then Placebo n=13 Participants 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).	Placebo First, Then Nitrate n=10 Participants 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).	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=10 Participants	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	10 Participants n=10 Participants	23 Participants n=23 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=10 Participants	0 Participants n=23 Participants
Age, Continuous	21 years STANDARD_DEVIATION 4 • n=13 Participants	22 years STANDARD_DEVIATION 4 • n=10 Participants	22 years STANDARD_DEVIATION 4 • n=23 Participants
Sex: Female, Male Female	0 Participants n=13 Participants	0 Participants n=10 Participants	0 Participants n=23 Participants
Sex: Female, Male Male	13 Participants n=13 Participants	10 Participants n=10 Participants	23 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Maximal Aerobic Capacity	53 ml/kg/min STANDARD_DEVIATION 6 • n=13 Participants	50 ml/kg/min STANDARD_DEVIATION 6 • n=10 Participants	51 ml/kg/min STANDARD_DEVIATION 6 • n=23 Participants

PRIMARY outcome

Timeframe: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia

Outcome measures

Outcome measures
Measure	Nitrate n=20 Participants 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).	Placebo n=20 Participants 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).
Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.	0.36 scores on a scale Standard Error 0.09	0.21 scores on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Measured on the sixth day of supplementation

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Nitrate n=15 Participants 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).	Placebo n=15 Participants 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).
Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.	666 seconds Standard Deviation 206	656 seconds Standard Deviation 184

Adverse Events

Nitrate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitrate n=23 participants at risk 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).	Placebo n=20 participants at risk 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).
Musculoskeletal and connective tissue disorders Chest Pain	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/20 • 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.

Additional Information

Dr Jamie Hugo Macdonald

Bangor Univeristy

Phone: +44 1248 38

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place